glycopyrrolate
- Product NDC
- 69452-406
- 11-digit product format
- 694520406
- Labeler code
- 69452
- Product ID
- 69452-406_512d3f1e-c35b-87c2-e063-6394a90a8de0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA220062
- Marketing category
- ANDA
- Marketing start
- 2026-05-11
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/5mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- glycopyrrolate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | 1 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 999961 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-406-88 | glycopyrrolate | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
| 69452-406-88 | glycopyrrolate | 1 in 1 CARTON | 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 |
|---|
| 69452-406-88 | 69452040688 | 1 BOTTLE in 1 CARTON (69452-406-88) / 473 mL in 1 BOTTLE | 1 bottle | 2026-05-11 | No | No | Current |