Glycopyrrolate
- Product NDC
- 0404-9775
- 11-digit product format
- 004049775
- Labeler code
- 0404
- Product ID
- 0404-9775_6b90d651-b13c-441c-ab12-8f866f0bfcbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA210083
- Marketing category
- ANDA
- Marketing start
- 2025-10-16
- 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 |
|---|
| 0404-9775-01 | Glycopyrrolate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 1 |
| 0404-9775-01 | Glycopyrrolate | 1 in 1 BAG | INJECTION, SOLUTION | 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 |
|---|
| 0404-9775-01 | 00404977501 | 1 VIAL in 1 BAG (0404-9775-01) / 1 mL in 1 VIAL | 1 vial | 2025-10-16 | No | No | Current |