Glycopyrrolate
- Product NDC
- 50090-4513
- 11-digit product format
- 500904513
- Labeler code
- 50090
- Product ID
- 50090-4513_5eb6b7fd-4ae9-4c39-b1ae-c9e2f4cace8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- A-S Medication Solutions
- Application
- ANDA208973
- Marketing category
- ANDA
- Marketing start
- 2017-06-15
- Marketing end
- 0000-00-00
- Substance
- GLYCOPYRROLATE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|---|---|---|---|---|
| 50090-4513-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-da27-0266-e053-dadaa90a7c1a | Glycopyrrolate Injection, USP Rx only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4513-0 | Glycopyrrolate | 1 mL in 1 VIAL | INJECTION | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4513-0 | ML - Milliliter | 50090-4513 | 08345a25-b969-426f-84f7-44298d27ed14 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4513 | GLYCOPYRROLATE INJECTION [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 1 package rows | 20210303_9bf13622-2aaa-4ec3-9f76-91856a1e7fe2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1731582 | glycopyrrolate 0.2 MG in 1 ML Injection | PSN | 9bf13622-2aaa-4ec3-9f76-91856a1e7fe2 | 4 |
| 1731582 | 1 ML glycopyrrolate 0.2 MG/ML Injection | SCD | 9bf13622-2aaa-4ec3-9f76-91856a1e7fe2 | 4 |
| 1731582 | glycopyrrolate 0.2 MG per 1 ML Injection | SY | 9bf13622-2aaa-4ec3-9f76-91856a1e7fe2 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4513-0 | 50090451300 | 1 mL in 1 VIAL (50090-4513-0) | 1 ml | 2019-09-06 | 0000-00-00 | No | No | Current |