Glycopyrrolate
- Product NDC
- 0641-6212
- 11-digit product format
- 006416212
- Labeler code
- 0641
- Product ID
- 0641-6212_9cafddcc-42f5-486b-9a17-46d75bd6227b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA017558
- Marketing category
- NDA
- Marketing start
- 2025-08-28
- Substance
- GLYCOPYRROLATE
- Active strength
- .2 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| V92SO9WP2I | GLYCOPYRROLATE | 51186-83-5 | GLYCOPYRROLATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6212-10 | 00641621210 | 10 SYRINGE, GLASS in 1 CARTON (0641-6212-10) / 1 mL in 1 SYRINGE, GLASS (0641-6212-01) | 2025-08-28 | No | No | Historical |