Glycopyrrolate Oral Solution
- Product NDC
- 51672-5316
- 11-digit product format
- 516725316
- Labeler code
- 51672
- Product ID
- 51672-5316_4e7def49-5c38-4c64-e063-6394a90a33c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate Oral Solution
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA212467
- Marketing category
- ANDA
- Marketing start
- 2022-07-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glycopyrrolate Oral Solution
- Listing expiration
- 2027-12-31
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 |
|---|
| 51672-5316-9 | Glycopyrrolate Oral Solution | 1 in 1 CARTON | LIQUID | 1 | | 5 |
| 51672-5316-9 | Glycopyrrolate Oral Solution | 500 mL in 1 BOTTLE | LIQUID | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-5316 | GLYCOPYRROLATE ORAL SOLUTION LIQUID [TARO PHARMACEUTICALS U.S.A. INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240110_e20c9a89-2a81-3c6e-e053-2995a90a9861.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 |
|---|
| 51672-5316-9 | 51672531609 | 1 BOTTLE in 1 CARTON (51672-5316-9) / 500 mL in 1 BOTTLE | 1 bottle | 2022-07-05 | 0000-00-00 | No | No | Current |