Glycopyrrolate
- Product NDC
- 68094-073
- 11-digit product format
- 680940073
- Labeler code
- 68094
- Product ID
- 68094-073_0a84301a-febc-4552-97d6-1fd16f191545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA204438
- Marketing category
- ANDA
- Marketing start
- 2025-07-07
- 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
- 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 |
|---|
| 68094-073-01 | Glycopyrrolate | 5 mL in 1 SYRINGE, PLASTIC | SOLUTION | 5 | | 3 |
| 68094-073-58 | Glycopyrrolate | 1 in 1 BAG | SOLUTION | 1 | | 3 |
| 68094-073-58 | Glycopyrrolate | 50 in 1 CASE | SOLUTION | 50 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-073-01 | 68094007301 | 5 mL in 1 SYRINGE, PLASTIC | 5 ml | | | | Historical |
| 68094-073-58 | 68094007358 | 50 BAG in 1 CASE (68094-073-58) / 1 SYRINGE, PLASTIC in 1 BAG / 5 mL in 1 SYRINGE, PLASTIC (68094-073-01) | 50 bag | 2025-07-07 | No | No | Historical |