Glycopyrrolate
- Product NDC
- 70518-4597
- 11-digit product format
- 705184597
- Labeler code
- 70518
- Product ID
- 70518-4597_4dec6029-9801-aee7-e063-6294a90af79c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207201
- Marketing category
- ANDA
- Marketing start
- 2026-03-25
- 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
- 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/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 |
|---|
| 70518-4597-0 | Glycopyrrolate | 100 in 1 BOX | TABLET | 100 | | 1 |
| 70518-4597-1 | Glycopyrrolate | 1 in 1 POUCH | TABLET | 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 |
|---|
| 70518-4597-0 | 70518459700 | 100 POUCH in 1 BOX (70518-4597-0) / 1 TABLET in 1 POUCH (70518-4597-1) | 100 pouch | 2026-03-25 | No | No | Current |
| 70518-4597-1 | 70518459701 | 1 in 1 POUCH | | | | | Historical |