Glycopyrrolate
- Product NDC
- 16571-744
- 11-digit product format
- 165710744
- Labeler code
- 16571
- Product ID
- 16571-744_9f8d9c4c-f326-4784-8ea4-f791613077f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- NDA012827
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-10-06
- Substance
- GLYCOPYRROLATE
- Active strength
- 2 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 197738, 197739 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-744-03 | Glycopyrrolate | 30 in 1 CONTAINER | TABLET | 30 | | 4 |
| 16571-744-09 | Glycopyrrolate | 90 in 1 CONTAINER | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-744 | GLYCOPYRROLATE TABLET [RISING PHARMA HOLDINGS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250126_58c4cb1f-59b8-4be9-a222-2264ca077d93.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 |
|---|
| 16571-744-03 | 16571074403 | 30 TABLET in 1 CONTAINER (16571-744-03) | 30 tablet | 2020-10-06 | 0000-00-00 | No | No | Current |
| 16571-744-09 | 16571074409 | 90 TABLET in 1 CONTAINER (16571-744-09) | 90 tablet | 2020-10-06 | 0000-00-00 | No | No | Current |