Padagis US LLC
Padagis US LLC lists 63 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 0574-0805 | Acetylcysteine Injection | Acetylcysteine 200 mg/mL | Rx |
| 0574-0520 | Actidose Suspension | Activated Charcoal 208 mg/mL | OTC |
| 0574-0521 | Actidose Aqua Suspension | Activated Charcoal 208 mg/mL | OTC |
| 0574-0292 | Amiloride hydrochloride Tablet | Amiloride Hydrochloride 5 mg/1 | Rx |
| 0574-7034 | Aspirin Suppository | Aspirin 300 mg/1 | OTC |
| 0574-7045 | Belladonna and Opium Suppository | Atropa Belladonna 16.2 mg/1; Opium 30 mg/1 | Rx |
| 0574-7040 | Belladonna and Opium Suppository | Atropa Belladonna 16.2 mg/1; Opium 60 mg/1 | Rx |
| 0574-0228 | Benazepril hydrochloride and hydrochlorothiazide Tablet | Benazepril Hydrochloride 20 mg/1; Hydrochlorothiazide 25 mg/1 | Rx |
| 0574-0229 | Benazepril hydrochloride and hydrochlorothiazide Tablet | Benazepril Hydrochloride 20 mg/1; Hydrochlorothiazide 12.5 mg/1 | Rx |
| 0574-7050 | Bisacodyl Suppository | Bisacodyl 10 mg/1 | OTC |
| 0574-4012 | Brinzolamide Suspension/ Drops | Brinzolamide 10 mg/mL | Rx |
| 0574-0106 | Bromocriptine mesylate Tablet | Bromocriptine Mesylate 2.5 mg/1 | Rx |
| 0574-1104 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Syrup | Brompheniramine Maleate 2 mg/5mL; Pseudoephedrine Hydrochloride 30 mg/5mL;… | Rx |
| 0574-9855 | Budesonide Capsule | Budesonide 3 mg/1 | Rx |
| 0574-2061 | Ciclopirox Gel | Ciclopirox 7.7 mg/g | Rx |
| 0574-0107 | Clotrimazole Lozenge | Clotrimazole 10 mg/1 | Rx |
| 0574-7226 | Compro Suppository | Prochlorperazine 25 mg/1 | Rx |
| 0574-2067 | Evamist Spray | Estradiol 1.53 mg/1 | Rx |
| 0574-0115 | Flavoxate Hydrochloride Tablet, Film Coated | Flavoxate Hydrochloride 100 mg/1 | Rx |
| 0574-7090 | Hydrocortisone Acetate Suppository | Hydrocortisone Acetate 25 mg/1 | Rx |
| 0574-7093 | Hydrocortisone Acetate Suppository | Hydrocortisone Acetate 30 mg/1 | Rx |
| 0574-0293 | Hydromorphone hydrochloride Tablet, Extended Release | Hydromorphone Hydrochloride 8 mg/1 | Rx |
| 0574-0297 | Hydromorphone hydrochloride Tablet, Extended Release | Hydromorphone Hydrochloride 32 mg/1 | Rx |
| 0574-7224 | Hydromorphone Hydrochloride Suppository | Hydromorphone Hydrochloride 3 mg/1 | Rx |
| 0574-0295 | Hydromorphone hydrochloride Tablet, Extended Release | Hydromorphone Hydrochloride 16 mg/1 | Rx |
| 0574-0294 | Hydromorphone hydrochloride Tablet, Extended Release | Hydromorphone Hydrochloride 12 mg/1 | Rx |
| 0574-1425 | Lenalidomide Capsule | Lenalidomide 25 mg/1 | Rx |
| 0574-1420 | Lenalidomide Capsule | Lenalidomide 20 mg/1 | Rx |
| 0574-1415 | Lenalidomide Capsule | Lenalidomide 15 mg/1 | Rx |
| 0574-1405 | Lenalidomide Capsule | Lenalidomide 5 mg/1 | Rx |
| 0574-1410 | Lenalidomide Capsule | Lenalidomide 10 mg/1 | Rx |
| 0574-1402 | Lenalidomide Capsule | Lenalidomide 2.5 mg/1 | Rx |
| 0574-2042 | Lidocaine And Prilocaine Cream | Lidocaine 25 mg/g; Prilocaine 25 mg/g | Rx |
| 0574-4135 | Loteprednol Etabonate Suspension/ Drops | Loteprednol Etabonate 5 mg/mL | Rx |
| 0574-4080 | Loteprednol Etabonate Suspension/ Drops | Loteprednol Etabonate 2 mg/mL | Rx |
| 0574-0791 | Methazolamide Tablet | Methazolamide 50 mg/1 | Rx |
| 0574-0790 | Methazolamide Tablet | Methazolamide 25 mg/1 | Rx |
| 0574-2410 | Methylphenidate Transdermal System Patch | Methylphenidate 27.5 mg/mg | Rx |
| 0574-2415 | Methylphenidate Transdermal System Patch | Methylphenidate 41.3 mg/mg | Rx |
| 0574-2420 | Methylphenidate Transdermal System Patch | Methylphenidate 55 mg/mg | Rx |
| 0574-2430 | Methylphenidate Transdermal System Patch | Methylphenidate 82.5 mg/mg | Rx |
| 0574-0150 | Midazolam Hydrochloride Syrup | Midazolam Hydrochloride 2 mg/mL | Rx |
| 0574-7114 | Morphine Sulfate Suppository | Morphine Sulfate 20 mg/1 | Rx |
| 0574-7116 | Morphine Sulfate Suppository | Morphine Sulfate 30 mg/1 | Rx |
| 0574-7112 | Morphine Sulfate Suppository | Morphine Sulfate 10 mg/1 | Rx |
| 0574-7110 | Morphine Sulfate Suppository | Morphine Sulfate 5 mg/1 | Rx |
| 0574-2008 | Nystop Powder | Nystatin 100000 [USP'U]/g | Rx |
| 0574-0279 | Paroxetine Capsule | Paroxetine Mesylate 7.5 mg/1 | Rx |
| 0574-0601 | Podocon 25 Tincture | Podophyllum Resin 1 mg/4mL | Rx |
| 0574-0611 | Podofilox Solution | Podofilox 5 mg/mL | Rx |
| 0574-0621 | Podofilox Gel | Podofilox 5 mg/g | Rx |
| 0574-1133 | Spironolactone Suspension | Spironolactone 25 mg/5mL | Rx |
| 0574-0827 | Testosterone Cypionate Injection, Solution | Testosterone Cypionate 200 mg/mL | Rx |
| 0574-0820 | Testosterone Cypionate Injection, Solution | Testosterone Cypionate 200 mg/mL | Rx |
| 0574-4031 | Tobramycin And Dexamethasone Suspension/ Drops | Tobramycin 3 mg/mL; Dexamethasone 1 mg/mL | Rx |
| 0574-1811 | Tofacitinib Citrate Tablet, Film Coated, Extended Release | Tofacitinib Citrate 11 mg/1 | Rx |
| 0574-2325 | Tretinoin Gel | Tretinoin .25 mg/g | Rx |
| 0574-2301 | Tretinoin Gel | Tretinoin .1 mg/g | Rx |
| 0574-2225 | Tretinoin Cream | Tretinoin .25 mg/g | Rx |
| 0574-2205 | Tretinoin Cream | Tretinoin .5 mg/g | Rx |
| 0574-2201 | Tretinoin Cream | Tretinoin 1 mg/g | Rx |
| 0574-0145 | Trospium Chloride Tablet, Film Coated | Trospium Chloride 20 mg/1 | Rx |
| 0574-0118 | Trospium Chloride ER Capsule, Extended Release | Trospium Chloride 60 mg/1 | Rx |
Recalls by Padagis US LLC
- D-0677-2026 Jul 22, 2026 · Class II
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. - D-0246-2025 Mar 5, 2025 · Class II
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. - D-0048-2025 Nov 27, 2024 · Class III
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing. - D-0139-2024 Dec 13, 2023 · Class II
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules - D-0081-2024 Nov 8, 2023 · Class II
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process. - D-0464-2023 Mar 22, 2023 · Class III
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. - D-1497-2022 Sep 7, 2022 · Class II
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. - D-0372-2022 Jan 19, 2022 · Class II
Defective Delivery System