Granules Pharmaceuticals Inc.
Granules Pharmaceuticals Inc. lists 138 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 70010-160 | Acetaminophen Tablet, Extended Release | Acetaminophen 650 mg/1 | OTC |
| 70010-161 | Acetaminophen Tablet | Acetaminophen 500 mg/1 | OTC |
| 70010-131 | Acetaminophen and Ibuprofen Tablet | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | OTC |
| 70010-213 | Acetaminophen and Ibuprofen Back Pain Tablet | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | OTC |
| 70010-040 | Amphetamine Sulfate Tablet | Amphetamine Sulfate 5 mg/1 | Rx |
| 70010-041 | Amphetamine Sulfate Tablet | Amphetamine Sulfate 10 mg/1 | Rx |
| 70010-784 | Bupropion hydrochloride Tablet, Extended Release | Bupropion Hydrochloride 150 mg/1 | Rx |
| 70010-785 | Bupropion hydrochloride Tablet, Extended Release | Bupropion Hydrochloride 300 mg/1 | Rx |
| 70010-127 | Bupropion Hydrochloride Tablet, Film Coated, Extended Release | Bupropion Hydrochloride 200 mg/1 | Rx |
| 70010-126 | Bupropion Hydrochloride Tablet, Film Coated, Extended Release | Bupropion Hydrochloride 150 mg/1 | Rx |
| 70010-125 | Bupropion Hydrochloride Tablet, Film Coated, Extended Release | Bupropion Hydrochloride 100 mg/1 | Rx |
| 70010-054 | butalbital and acetaminophen Capsule | Butalbital 50 mg/1; Acetaminophen 300 mg/1 | Rx |
| 70010-149 | Butalbital, Acetaminophen and Caffeine Tablet | Butalbital 50 mg/1; Acetaminophen 325 mg/1; Caffeine 40 mg/1 | Rx |
| 70010-044 | Butalbital, Acetaminophen and Caffeine Capsule | Butalbital 50 mg/1; Acetaminophen 300 mg/1; Caffeine 40 mg/1 | Rx |
| 70010-163 | Cetirizine hydrochloride Tablet, Coated | Cetirizine Hydrochloride 10 mg/1 | OTC |
| 70010-293 | Cetirizine hydrochloride - HIVES Tablet, Coated | Cetirizine Hydrochloride 10 mg/1 | OTC |
| 70010-229 | Clotrimazole Solution | Clotrimazole 1 g/mL | OTC |
| 70010-002 | Colchicine Tablet, Film Coated | Colchicine .6 mg/1 | Rx |
| 70010-004 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 5 mg/1 | Rx |
| 70010-010 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 35 mg/1 | Rx |
| 70010-008 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 25 mg/1 | Rx |
| 70010-007 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 20 mg/1 | Rx |
| 70010-009 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 30 mg/1 | Rx |
| 70010-006 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 15 mg/1 | Rx |
| 70010-005 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 10 mg/1 | Rx |
| 70010-011 | Dexmethylphenidate Hydrochloride Capsule, Extended Release | Dexmethylphenidate Hydrochloride 40 mg/1 | Rx |
| 70010-034 | dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Capsule, Extended Release | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1;… | Rx |
| 70010-033 | dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Capsule, Extended Release | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1;… | Rx |
| 70010-032 | dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Capsule, Extended Release | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1;… | Rx |
| 70010-031 | dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Capsule, Extended Release | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1;… | Rx |
| 70010-030 | dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Capsule, Extended Release | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1;… | Rx |
| 70010-029 | dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Capsule, Extended Release | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1;… | Rx |
| 70010-113 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1;… | Rx |
| 70010-114 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Dextroamphetamine Saccharate 3.125 mg/1; Amphetamine Aspartate Monohydrate 3.125 mg/1;… | Rx |
| 70010-111 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1;… | Rx |
| 70010-115 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1;… | Rx |
| 70010-116 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1;… | Rx |
| 70010-117 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… | Rx |
| 70010-112 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet | Dextroamphetamine Saccharate 1.875 mg/1; Amphetamine Aspartate Monohydrate 1.875 mg/1;… | Rx |
| 70010-024 | Dofetilide 0.125mg Capsule | Dofetilide .125 mg/1 | Rx |
| 70010-025 | Dofetilide 0.25mg Capsule | Dofetilide .25 mg/1 | Rx |
| 70010-026 | Dofetilide 0.5mg Capsule | Dofetilide .5 mg/1 | Rx |
| 70010-133 | Esomeprazole magnesium Capsule, Delayed Release | Esomeprazole Magnesium 20 mg/1 | Rx |
| 70010-134 | Esomeprazole magnesium Capsule, Delayed Release | Esomeprazole Magnesium 40 mg/1 | Rx |
| 70010-183 | Fexofenadine HCL Tablet | Fexofenadine Hydrochloride 180 mg/1 | OTC |
| 70010-228 | Gabapentin Tablet, Film Coated | Gabapentin 800 mg/1 | Rx |
| 70010-227 | Gabapentin Tablet, Film Coated | Gabapentin 600 mg/1 | Rx |
| 70010-928 | Gabapentin Capsule | Gabapentin 400 mg/1 | Rx |
| 70010-927 | Gabapentin Capsule | Gabapentin 300 mg/1 | Rx |
| 70010-926 | Gabapentin Capsule | Gabapentin 100 mg/1 | Rx |
| 70010-106 | Glycopyrrolate Oral Solution Solution | Glycopyrrolate 1 mg/5mL | Rx |
| 70010-199 | Guaifenesin Tablet, Extended Release | Guaifenesin 600 mg/1 | OTC |
| 70010-672 | Hydrocodone Bitartrate and Acetaminophen Tablet | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 | Rx |
| 70010-673 | Hydrocodone Bitartrate and Acetaminophen Tablet | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | Rx |
| 70010-674 | Hydrocodone Bitartrate and Acetaminophen Tablet | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 | Rx |
| 70010-068 | Ibuprofen Tablet, Film Coated | Ibuprofen 800 mg/1 | Rx |
| 70010-067 | Ibuprofen Tablet, Film Coated | Ibuprofen 600 mg/1 | Rx |
| 70010-066 | Ibuprofen Tablet, Film Coated | Ibuprofen 400 mg/1 | Rx |
| 70010-522 | Levetiracetam Tablet, Film Coated | Levetiracetam 500 mg/1 | Rx |
| 70010-521 | Levetiracetam Tablet, Film Coated | Levetiracetam 250 mg/1 | Rx |
| 70010-523 | Levetiracetam Tablet, Film Coated | Levetiracetam 750 mg/1 | Rx |
| 70010-524 | Levetiracetam Tablet, Film Coated | Levetiracetam 1000 mg/1 | Rx |
| 70010-217 | Lisdexamfetamine dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate 40 mg/1 | Rx |
| 70010-206 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 10 mg/1 | Rx |
| 70010-207 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 20 mg/1 | Rx |
| 70010-208 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 30 mg/1 | Rx |
| 70010-209 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 40 mg/1 | Rx |
| 70010-210 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 50 mg/1 | Rx |
| 70010-211 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 60 mg/1 | Rx |
| 70010-219 | Lisdexamfetamine dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate 60 mg/1 | Rx |
| 70010-212 | Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate 70 mg/1 | Rx |
| 70010-214 | Lisdexamfetamine dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate 10 mg/1 | Rx |
| 70010-215 | Lisdexamfetamine dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate 20 mg/1 | Rx |
| 70010-216 | Lisdexamfetamine dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate 30 mg/1 | Rx |
| 70010-218 | Lisdexamfetamine dimesylate Tablet, Chewable | Lisdexamfetamine Dimesylate 50 mg/1 | Rx |
| 70010-162 | Loratadine Tablet | Loratadine 10 mg/1 | OTC |
| 70010-741 | Losartan Potassium Tablet | Losartan Potassium 25 mg/1 | Rx |
| 70010-743 | Losartan Potassium Tablet | Losartan Potassium 100 mg/1 | Rx |
| 70010-742 | Losartan Potassium Tablet | Losartan Potassium 50 mg/1 | Rx |
| 70010-189 | Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated | Losartan Potassium 100 mg/1; Hydrochlorothiazide 25 mg/1 | Rx |
| 70010-188 | Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated | Losartan Potassium 100 mg/1; Hydrochlorothiazide 12.5 mg/1 | Rx |
| 70010-187 | Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated | Losartan Potassium 50 mg/1; Hydrochlorothiazide 12.5 mg/1 | Rx |
| 70010-492 | Metformin Tablet, Extended Release | Metformin Hydrochloride 750 mg/1 | Rx |
| 70010-491 | Metformin Tablet, Extended Release | Metformin Hydrochloride 500 mg/1 | Rx |
| 70010-497 | Metformin Hydrochloride Tablet, Extended Release | Metformin Hydrochloride 1000 mg/1 | Rx |
| 70010-496 | Metformin Hydrochloride Tablet, Extended Release | Metformin Hydrochloride 500 mg/1 | Rx |
| 70010-065 | Metformin Hydrochloride Tablet | Metformin Hydrochloride 1000 mg/1 | Rx |
| 70010-063 | Metformin Hydrochloride Tablet | Metformin Hydrochloride 500 mg/1 | Rx |
| 70010-064 | Metformin Hydrochloride Tablet | Metformin Hydrochloride 850 mg/1 | Rx |
| 70010-770 | Methocarbamol Tablet, Coated | Methocarbamol 750 mg/1 | Rx |
| 70010-754 | Methocarbamol Tablet, Coated | Methocarbamol 500 mg/1 | Rx |
| 70010-786 | Methylergonovine Maleate Tablet | Methylergonovine Maleate .2 mg/1 | Rx |
| 70010-042 | Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride 10 mg/1 | Rx |
| 70010-016 | Methylphenidate Hydrochloride Capsule, Extended Release | Methylphenidate Hydrochloride 60 mg/1 | Rx |
| 70010-015 | Methylphenidate Hydrochloride Capsule, Extended Release | Methylphenidate Hydrochloride 40 mg/1 | Rx |
| 70010-014 | Methylphenidate Hydrochloride Capsule, Extended Release | Methylphenidate Hydrochloride 30 mg/1 | Rx |
| 70010-013 | Methylphenidate Hydrochloride Capsule, Extended Release | Methylphenidate Hydrochloride 20 mg/1 | Rx |
| 70010-012 | Methylphenidate Hydrochloride Capsule, Extended Release | Methylphenidate Hydrochloride 10 mg/1 | Rx |
| 70010-043 | Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride 20 mg/1 | Rx |
| 70010-780 | Metoprolol Succinate Tablet, Film Coated, Extended Release | Metoprolol Succinate 25 mg/1 | Rx |
| 70010-781 | Metoprolol Succinate Tablet, Film Coated, Extended Release | Metoprolol Succinate 50 mg/1 | Rx |
| 70010-782 | Metoprolol Succinate Tablet, Film Coated, Extended Release | Metoprolol Succinate 100 mg/1 | Rx |
| 70010-783 | Metoprolol Succinate Tablet, Film Coated, Extended Release | Metoprolol Succinate 200 mg/1 | Rx |
| 70010-138 | Naproxen Tablet | Naproxen 375 mg/1 | Rx |
| 70010-137 | Naproxen Tablet | Naproxen 250 mg/1 | Rx |
| 70010-139 | Naproxen Tablet | Naproxen 500 mg/1 | Rx |
| 70010-670 | Oxycodone and Acetaminophen Tablet | Oxycodone Hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | Rx |
| 70010-669 | Oxycodone and Acetaminophen Tablet | Oxycodone Hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | Rx |
| 70010-668 | Oxycodone and Acetaminophen Tablet | Oxycodone Hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | Rx |
| 70010-667 | Oxycodone and Acetaminophen Tablet | Acetaminophen 325 mg/1; Oxycodone Hydrochloride 2.5 mg/1 | Rx |
| 70010-190 | pantoprazole sodium Tablet, Delayed Release | Pantoprazole Sodium 20 mg/1 | Rx |
| 70010-191 | pantoprazole sodium Tablet, Delayed Release | Pantoprazole Sodium 40 mg/1 | Rx |
| 70010-907 | Penicillamine Capsule | Penicillamine 250 mg/1 | Rx |
| 70010-148 | Potassium Chloride Capsule, Extended Release | Potassium Chloride 750 mg/1 | Rx |
| 70010-147 | Potassium Chloride Capsule, Extended Release | Potassium Chloride 600 mg/1 | Rx |
| 70010-073 | Potassium Chloride Solution | Potassium Chloride 40 meq/15mL | Rx |
| 70010-072 | Potassium Chloride Solution | Potassium Chloride 20 meq/15mL | Rx |
| 70010-021 | Potassium Chloride Extended Release Tablet, Extended Release | Potassium Chloride 600 mg/1 | Rx |
| 70010-022 | Potassium Chloride Extended Release Tablet, Extended Release | Potassium Chloride 750 mg/1 | Rx |
| 70010-136 | Potassium Chloride Extended-release Tablet, Extended Release | Potassium Chloride 750 mg/1 | Rx |
| 70010-135 | Potassium Chloride Extended-release Tablet, Extended Release | Potassium Chloride 1500 mg/1 | Rx |
| 70010-071 | Potassium Chloride for Oral Solution For Solution | Potassium Chloride 1.5 g/1.58g | Rx |
| 70010-086 | Prazosin Hydrochloride Capsule | Prazosin Hydrochloride 5 mg/1 | Rx |
| 70010-084 | Prazosin Hydrochloride Capsule | Prazosin Hydrochloride 1 mg/1 | Rx |
| 70010-085 | Prazosin Hydrochloride Capsule | Prazosin Hydrochloride 2 mg/1 | Rx |
| 70010-028 | Ramelteon Tablet | Ramelteon 8 mg/1 | Rx |
| 70010-205 | Sertraline hydrochloride Tablet, Film Coated | Sertraline Hydrochloride 100 mg/1 | Rx |
| 70010-204 | Sertraline hydrochloride Tablet, Film Coated | Sertraline Hydrochloride 50 mg/1 | Rx |
| 70010-203 | Sertraline hydrochloride Tablet, Film Coated | Sertraline Hydrochloride 25 mg/1 | Rx |
| 70010-231 | Trazodone Hydrochloride Tablet | Trazodone Hydrochloride 50 mg/1 | Rx |
| 70010-232 | Trazodone Hydrochloride Tablet | Trazodone Hydrochloride 100 mg/1 | Rx |
| 70010-233 | Trazodone Hydrochloride Tablet | Trazodone Hydrochloride 150 mg/1 | Rx |
| 70010-234 | Trazodone Hydrochloride Tablet | Trazodone Hydrochloride 300 mg/1 | Rx |
| 70010-027 | Trospium Chloride Capsule, Extended Release | Trospium Chloride 60 mg/1 | Rx |
| 70010-051 | Valganciclovir Hydrochloride For Solution | Valganciclovir 50 mg/mL | Rx |
| 70010-184 | Venlafaxine Hydrochloride Capsule, Extended Release | Venlafaxine Hydrochloride 37.5 mg/1 | Rx |
| 70010-185 | Venlafaxine Hydrochloride Capsule, Extended Release | Venlafaxine Hydrochloride 75 mg/1 | Rx |
| 70010-186 | Venlafaxine Hydrochloride Capsule, Extended Release | Venlafaxine Hydrochloride 150 mg/1 | Rx |
Recalls by Granules Pharmaceuticals Inc.
- D-0305-2026 Feb 11, 2026 · Class II
Presence of Foreign Tablets/Capsules - D-0673-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0672-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0671-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0670-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0669-2025 Oct 1, 2025 · Class III
Failed Impurities/Degradation Specifications: - D-0510-2025 Jul 9, 2025 · Class II
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. - D-0192-2025 Jan 15, 2025 · Class II
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. - D-0187-2025 Jan 15, 2025 · Class II
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. - D-0634-2024 Aug 14, 2024 · Class II
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets