Glimepiride
- Product NDC
- 50090-3189
- 11-digit product format
- 500903189
- Labeler code
- 50090
- Product ID
- 50090-3189_fe75a569-7eba-4144-8159-4b2145b1b341
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202112
- Marketing category
- ANDA
- Marketing start
- 2015-07-14
- Marketing end
- 0000-00-00
- Substance
- GLIMEPIRIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3189-0 | 2023-07-12 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-1 | 2023-07-12 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-3 | 2023-07-12 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-4 | 2023-07-12 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
| 50090-3189-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-e0a0-0266-e053-dadaa90a7c1a | 669994d1-0ea1-45cc-9406-2d5f86077134 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3189-0 | EA - Each | 50090-3189 | 0f212d10-f3d0-4923-b828-99643930fc22 | 1 | 2018-12-13 |
| 50090-3189-1 | EA - Each | 50090-3189 | 8b241e18-0bea-4591-921d-cd236e514bb2 | 1 | 2020-03-10 |
| 50090-3189-3 | EA - Each | 50090-3189 | c510907d-3f9b-48a1-b98a-01b4bdfaccf1 | 1 | 2020-03-10 |
| 50090-3189-4 | EA - Each | 50090-3189 | b75c2814-8674-4da2-91f0-4b4ffd1268b6 | 1 | 2020-03-10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-3189-1 | 50090318901 | 100 TABLET in 1 BOTTLE, PLASTIC (50090-3189-1) | 100 tablet | 2015-07-14 | 0000-00-00 | No | No | Current |
| 50090-3189-3 | 50090318903 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-3189-3) | 90 tablet | 2015-07-14 | 0000-00-00 | No | No | Current |
| 50090-3189-4 | 50090318904 | 180 TABLET in 1 BOTTLE, PLASTIC (50090-3189-4) | 180 tablet | 2015-07-14 | 0000-00-00 | No | No | Current |