NDC 16729-471 – Glycopyrrolate
Glycopyrrolate .2 mg/mL · Injection · Intramuscular, Intravenous
Product NDC16729-471
Product details
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Labeler
- Accord Healthcare, Inc.,
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Marketing category
- ANDA · ANDA213238
- Marketed since
- December 17, 2020
- Listing expires
- December 31, 2026
- Pharmacologic class
- Anticholinergic; Cholinergic Muscarinic Antagonist
Active ingredients
- Glycopyrrolate .2 mg/mL
Uses, dosage, side effects and warnings for Glycopyrrolate →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 16729-471-08 | 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-471-08) / 1 mL in 1 VIAL, SINGLE-DOSE | Dec 17, 2020 |
Recalls mentioning this NDC
- D-0398-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0396-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0397-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0399-2023 Mar 8, 2023 · Class II
CGMP Deviations: recalling drug products following an FDA inspection. - D-0250-2021 Feb 17, 2021 · Class III
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Other Glycopyrrolate products
- 16729-473 Glycopyrrolate .2 mg/mL · Injection · Accord Healthcare, Inc.,
- 16729-474 Glycopyrrolate .2 mg/mL · Injection · Accord Healthcare, Inc.,
- 16729-472 Glycopyrrolate .2 mg/mL · Injection · Accord Healthcare, Inc.,
- 62332-607 Glycopyrrolate .2 mg/mL · Injection · Alembic Pharmaceuticals Inc.
- 62332-629 Glycopyrrolate .2 mg/mL · Injection · Alembic Pharmaceuticals Inc.
- 62332-628 Glycopyrrolate .2 mg/mL · Injection · Alembic Pharmaceuticals Inc.
- 62332-627 Glycopyrrolate .2 mg/mL · Injection · Alembic Pharmaceuticals Inc.
- 70121-1396 Glycopyrrolate 1 mg/5mL · Injection · Amneal Pharmaceuticals LLC
- 70121-1394 Glycopyrrolate .2 mg/mL · Injection · Amneal Pharmaceuticals LLC
- 70121-1395 Glycopyrrolate .4 mg/2mL · Injection · Amneal Pharmaceuticals LLC
- 70121-1397 Glycopyrrolate 4 mg/20mL · Injection · Amneal Pharmaceuticals LLC
- 71839-123 Glycopyrrolate .2 mg/mL · Injection · BE Pharmaceuticals Inc.