Glycopyrrolate
- Product NDC
- 71921-110
- 11-digit product format
- 719210110
- Labeler code
- 71921
- Product ID
- 71921-110_2cda1ed5-10bb-4651-acbf-be44ad709665
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA091182
- Marketing category
- ANDA
- Marketing start
- 2026-02-12
- 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 |
|---|---|
| GLYCOPYRROLATE | 1 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V92SO9WP2I |
| Rxcui | 197738, 197739 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 138c3de2-4b03-4255-92b5-f022482d81bc | Product name | 4 | 20260113 |
| 4dc252b1-bb5f-8bb6-4fa8-f3a45efd810e | Product name | 5 | 20250304 |
| f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b | Product name | 1 | 20231002 |
| 76dcac30-469f-4f92-9c55-70950d209446 | Product name | 1 | 20230809 |
| 132196a6-5117-4b6e-a9dd-27f2793580c6 | Product name | 1 | 20230112 |
| ac1f888b-a1db-4d2e-abbc-973f21c2ce1b | Product name | 1 | 20220720 |
| d84dd569-7bf0-1410-25eb-017ef37dd406 | Product name | 9 | 20210902 |
| 7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a | Product name | 1 | 20210204 |
| 58b12de9-b891-41c7-9be6-ff47de5ec28b | Product name | 1 | 20180828 |
| 9aff7b10-8e47-4b10-9a92-803440a37ce2 | Product name | 1 | 20180206 |
| ce066c73-ca6f-49fc-83d4-d3cf6728e8a1 | Product name | 1 | 20160616 |
| fb29b8a9-c2d0-42bb-aea8-9bc2a87db75a | Product name | 1 | 20151113 |
| ab7ba50c-5a47-47e6-8dd6-fa32a52559f6 | Product name | 1 | 20151109 |
| 29ae08d1-069f-9822-4820-152d5dc67797 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71921-110-01 | Glycopyrrolate | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71921-110-01 | EA - Each | 71921-110 | 0d0e128b-6fcd-47d3-8b31-05c1e1795c2b | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197738 | glycopyrrolate 1 MG Oral Tablet | PSN | 2cda1ed5-10bb-4651-acbf-be44ad709665 | 1 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | PSN | 2cda1ed5-10bb-4651-acbf-be44ad709665 | 1 |
| 197738 | glycopyrrolate 1 MG Oral Tablet | SCD | 2cda1ed5-10bb-4651-acbf-be44ad709665 | 1 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | SCD | 2cda1ed5-10bb-4651-acbf-be44ad709665 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71921-110-01 | 71921011001 | 100 TABLET in 1 BOTTLE (71921-110-01) | 100 tablet | 2026-02-12 | No | No | Historical |