Irbesartan
- Product NDC
- 57297-412
- 11-digit product format
- 572970412
- Labeler code
- 57297
- Product ID
- 57297-412_d68faa18-807b-4fc0-808f-b00378a68a41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irbesartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- LUPIN LIMITED
- Application
- ANDA201531
- Marketing category
- ANDA
- Marketing start
- 2012-10-23
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57297-412-02 | 2024-12-27 | C162847 | 48780-1 | 9d75b9d1-0df5-f424-e053-dadaa90a57ce | e5747bdd-4f40-401a-bfb0-65e31ae93aa2 |
| 57297-412-06 | 2024-12-27 | C162847 | 48780-1 | 9d75b9d1-0df5-f424-e053-dadaa90a57ce | e5747bdd-4f40-401a-bfb0-65e31ae93aa2 |
| 57297-412-09 | 2024-12-27 | C162847 | 48780-1 | 9d75b9d1-0df5-f424-e053-dadaa90a57ce | e5747bdd-4f40-401a-bfb0-65e31ae93aa2 |
| 57297-412-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0df5-f424-e053-dadaa90a57ce | e5747bdd-4f40-401a-bfb0-65e31ae93aa2 |
| 57297-412-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0df5-f424-e053-dadaa90a57ce | e5747bdd-4f40-401a-bfb0-65e31ae93aa2 |
| 57297-412-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0df5-f424-e053-dadaa90a57ce | e5747bdd-4f40-401a-bfb0-65e31ae93aa2 |