Glycopyrrolate
- Product NDC
- 31722-016
- 11-digit product format
- 317220016
- Labeler code
- 31722
- Product ID
- 31722-016_e3b10753-2b28-5dd9-e053-2995a90a8687
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA213698
- Marketing category
- ANDA
- Marketing start
- 2022-07-05
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/5mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic 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 |
|---|
| 31722-016-47 | Glycopyrrolate | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
| 31722-016-47 | Glycopyrrolate | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-016 | GLYCOPYRROLATE SOLUTION [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220715_4741be85-3abb-4545-aba9-281f64d210ec.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 |
|---|
| 31722-016-47 | 31722001647 | 1 BOTTLE in 1 CARTON (31722-016-47) / 473 mL in 1 BOTTLE | 1 bottle | 2022-07-05 | 0000-00-00 | No | No | Current |