GLYCOPYRROLATE
- Product NDC
- 84549-543
- 11-digit product format
- 845490543
- Labeler code
- 84549
- Product ID
- 84549-543_3edcc39d-0e2a-4585-e063-6394a90ad512
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA210927
- Marketing category
- ANDA
- Marketing start
- 2019-03-20
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GLYCOPYRROLATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | .2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 1731582 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-543-25 | GLYCOPYRROLATE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-543-25 | 84549054325 | 1 mL in 1 VIAL, SINGLE-DOSE (84549-543-25) | 1 ml | 2025-09-15 | No | No | Historical |