Glycopyrrolate
- Product NDC
- 49884-066
- 11-digit product format
- 498840066
- Labeler code
- 49884
- Product ID
- 49884-066_1b923cd6-6a35-4f2f-bcb8-cab438977a08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA040653
- Marketing category
- ANDA
- Marketing start
- 2006-09-26
- 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
- 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 |
|---|---|
| GLYCOPYRROLATE | 2 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 |
|---|---|---|---|---|---|---|
| 49884-066-01 | Glycopyrrolate | 100 in 1 BOTTLE | TABLET | 100 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-066-01 | EA - Each | 49884-066 | 737bf3e5-179b-4a42-9e82-5eb562b6191b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLYCOPYRROLATE | ACTIVE INGREDIENT | V92SO9WP2I | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 | |
| GLYCOPYRROLATE | ACTIVE MOIETY | V92SO9WP2I | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197739 | glycopyrrolate 2 MG Oral Tablet | PSN | 987ba524-361e-49c3-9e00-550a78748542 | 103 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | PSN | fcb295e4-038f-4d4f-8786-4fbcd1d3c298 | 103 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | SCD | 987ba524-361e-49c3-9e00-550a78748542 | 103 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | SCD | fcb295e4-038f-4d4f-8786-4fbcd1d3c298 | 103 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | PSN | 33bbc475-2fe3-48ab-8a9d-56d13053593e | 101 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | SCD | 33bbc475-2fe3-48ab-8a9d-56d13053593e | 101 |
| 197738 | glycopyrrolate 1 MG Oral Tablet | PSN | 1f266d77-4f9e-44c9-a000-2f8fea3ac80b | 6 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | PSN | 1f266d77-4f9e-44c9-a000-2f8fea3ac80b | 6 |
| 197738 | glycopyrrolate 1 MG Oral Tablet | SCD | 1f266d77-4f9e-44c9-a000-2f8fea3ac80b | 6 |
| 197739 | glycopyrrolate 2 MG Oral Tablet | SCD | 1f266d77-4f9e-44c9-a000-2f8fea3ac80b | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49884-066-01 | 49884006601 | 100 TABLET in 1 BOTTLE (49884-066-01) | 100 tablet | 2006-09-26 | 0000-00-00 | No | No | Current |