IRBESARTAN
- Product NDC
- 50090-3269
- 11-digit product format
- 500903269
- Labeler code
- 50090
- Product ID
- 50090-3269_32265c04-5b29-40e1-9cc7-218ea79b393c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA203534
- Marketing category
- ANDA
- Marketing start
- 2015-02-24
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3269-0 | 2023-02-06 | C162847 | 48780-1 | f386c64a-2ada-0266-e053-dadaa90a7c1a | 6425184c-5999-452f-8df2-4eb9f538c1d6 |
| 50090-3269-1 | 2023-02-06 | C162847 | 48780-1 | f386c64a-2ada-0266-e053-dadaa90a7c1a | 6425184c-5999-452f-8df2-4eb9f538c1d6 |
| 50090-3269-2 | 2023-02-06 | C162847 | 48780-1 | f386c64a-2ada-0266-e053-dadaa90a7c1a | 6425184c-5999-452f-8df2-4eb9f538c1d6 |
| 50090-3269-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2ada-0266-e053-dadaa90a7c1a | 6425184c-5999-452f-8df2-4eb9f538c1d6 |
| 50090-3269-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2ada-0266-e053-dadaa90a7c1a | 6425184c-5999-452f-8df2-4eb9f538c1d6 |
| 50090-3269-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2ada-0266-e053-dadaa90a7c1a | 6425184c-5999-452f-8df2-4eb9f538c1d6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3269-0 | EA - Each | 50090-3269 | 7903e2db-a9c0-4389-870c-ab708093c135 | 1 | 2019-05-02 |
| 50090-3269-1 | EA - Each | 50090-3269 | 737db3d3-95bc-47e5-8860-f73517f8c04e | 1 | 2021-09-07 |
| 50090-3269-2 | EA - Each | 50090-3269 | 2842898e-c11f-4da8-b370-ef86c7c13d6c | 1 | 2019-05-02 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-3269-0 | 50090326900 | 30 TABLET in 1 BOTTLE (50090-3269-0) | 30 tablet | 2017-11-17 | 0000-00-00 | No | No | Current |
| 50090-3269-1 | 50090326901 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-3269-1) | 90 tablet | 2015-02-24 | 0000-00-00 | No | No | Current |
| 50090-3269-2 | 50090326902 | 90 TABLET in 1 BOTTLE (50090-3269-2) | 90 tablet | 2018-03-15 | 0000-00-00 | No | No | Current |