Glycopyrrolate Oral Solution
- Product NDC
- 82983-428
- 11-digit product format
- 829830428
- Labeler code
- 82983
- Product ID
- 82983-428_80036e14-8ef8-4d3e-a6c5-4bfca592dd79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- AJENAT PHARMACEUTICALS LLC
- Application
- ANDA219267
- Marketing category
- ANDA
- Marketing start
- 2025-12-12
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glycopyrrolate Oral Solution
- Listing expiration
- 2026-12-31
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 |
|---|
| 82983-428-47 | Glycopyrrolate Oral Solution | 1 in 1 BOTTLE | SOLUTION | 1 | | 2 |
| 82983-428-47 | Glycopyrrolate Oral Solution | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82983-428-47 | 82983042847 | 1 BOTTLE in 1 BOTTLE (82983-428-47) / 473 mL in 1 BOTTLE | 1 bottle | 2025-12-12 | No | No | Current |