GLYCOPYRROLATE
- Product NDC
- 60687-458
- 11-digit product format
- 606870458
- Labeler code
- 60687
- Product ID
- 60687-458_35bc723d-9108-57f9-e063-6394a90a5069
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYCOPYRROLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA202675
- Marketing category
- ANDA
- Marketing start
- 2025-05-18
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 197738 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-458-01 | GLYCOPYRROLATE | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 3 |
| 60687-458-11 | GLYCOPYRROLATE | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-458 | GLYCOPYRROLATE TABLET [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250524_6404fc8e-d109-4950-9dca-c8a85ad90cf3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60687-458-01 | 60687045801 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-458-01) / 1 TABLET in 1 BLISTER PACK (60687-458-11) | 100 blister pack | 2025-05-18 | 0000-00-00 | No | No | Current |
| 60687-458-11 | 60687045811 | 1 in 1 BLISTER PACK | | | | | | Historical |