Glycopyrrolate
- Product NDC
- 0722-7097
- 11-digit product format
- 007227097
- Labeler code
- 0722
- Product ID
- 0722-7097_9e901d90-08ba-4143-8e0c-1bd15b72e0de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nexgen Pharma, Inc.
- Application
- ANDA091522
- Marketing category
- ANDA
- Marketing start
- 2012-03-12
- Marketing end
- 0000-00-00
- Substance
- GLYCOPYRROLATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0722-7097-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3c90-a910-e053-dadaa90a0b85 | GLYCOPYRROLATE TABLETS, USP, 1.5 MG |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0722-7097-01 | Glycopyrrolate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLYCOPYRROLATE | ACTIVE INGREDIENT | V92SO9WP2I | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 | |
| GLYCOPYRROLATE | ACTIVE MOIETY | V92SO9WP2I | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 | |
| CALCIUM PYROPHOSPHATE | INACTIVE INGREDIENT | X69NU20D19 | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLYCOPYRROLATE TABLET [NEXGEN PHARMA, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1247658 | glycopyrrolate 1.5 MG Oral Tablet | PSN | 06bb6f89-4694-4aaa-8bff-f7f3c81d3add | 3 |
| 1247658 | glycopyrrolate 1.5 MG Oral Tablet | SCD | 06bb6f89-4694-4aaa-8bff-f7f3c81d3add | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0722-7097-01 | 00722709701 | 100 in 1 BOTTLE, PLASTIC | Historical |