glycopyrrolate
- Product NDC
- 71656-061
- 11-digit product format
- 716560061
- Labeler code
- 71656
- Product ID
- 71656-061_26be665a-acae-22fd-e063-6394a90a2a0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Saptalis Pharmaceuticals, LLC.
- Application
- ANDA216297
- Marketing category
- ANDA
- Marketing start
- 2024-11-25
- 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 |
|---|
| 71656-061-16 | glycopyrrolate | 1 in 1 BOTTLE | SOLUTION | 1 | | 2 |
| 71656-061-16 | glycopyrrolate | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71656-061 | GLYCOPYRROLATE SOLUTION [SAPTALIS PHARMACEUTICALS, LLC.] | 2 | Current NDC, 2 package rows | 20241126_3e6f8091-d6fe-4c8f-b897-606a70bf74bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71656-061-16 | 71656006116 | 1 BOTTLE in 1 BOTTLE (71656-061-16) / 473 mL in 1 BOTTLE | 1 bottle | 2024-11-25 | No | No | Current |