Irbesartan
- Product NDC
- 43547-278
- 11-digit product format
- 435470278
- Labeler code
- 43547
- Product ID
- 43547-278_eff37327-ff5c-4b80-9ffe-3ab00635bd3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco healthcare U.S., LLC
- Application
- ANDA203071
- Marketing category
- ANDA
- Marketing start
- 2012-09-27
- Marketing end
- 0000-00-00
- Substance
- IRBESARTAN
- Active strength
- 150 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43547-278-03 | 2024-02-20 | C162847 | 48780-1 | 9d75b9d0-eaa3-f424-e053-dadaa90a57ce | 0f96b0f6-c1c9-4191-916c-507b384d2136 |
| 43547-278-09 | 2024-02-20 | C162847 | 48780-1 | 9d75b9d0-eaa3-f424-e053-dadaa90a57ce | 0f96b0f6-c1c9-4191-916c-507b384d2136 |
| 43547-278-50 | 2024-02-20 | C162847 | 48780-1 | 9d75b9d0-eaa3-f424-e053-dadaa90a57ce | 0f96b0f6-c1c9-4191-916c-507b384d2136 |
| 43547-278-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eaa3-f424-e053-dadaa90a57ce | 0f96b0f6-c1c9-4191-916c-507b384d2136 |
| 43547-278-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eaa3-f424-e053-dadaa90a57ce | 0f96b0f6-c1c9-4191-916c-507b384d2136 |
| 43547-278-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eaa3-f424-e053-dadaa90a57ce | 0f96b0f6-c1c9-4191-916c-507b384d2136 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-278-03 | EA - Each | 43547-278 | 18ee2eea-6564-4186-95f0-e6f31dbcd2c5 | 1 | 2013-02-13 |
| 43547-278-09 | EA - Each | 43547-278 | 5fb469eb-f955-4e86-8ec8-694e3680cd65 | 1 | 2013-02-13 |
| 43547-278-50 | EA - Each | 43547-278 | 44794d61-dad2-4c48-a545-2e05a019a891 | 1 | 2013-02-13 |