Amlodipine and Valsartan
- Product NDC
- 57297-765
- 11-digit product format
- 572970765
- Labeler code
- 57297
- Product ID
- 57297-765_40b74a8d-c376-4e6c-92cb-22604cbb1317
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- LUPIN LIMITED
- Application
- ANDA090245
- Marketing category
- ANDA
- Marketing start
- 2015-03-30
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; VALSARTAN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],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 |
|---|---|---|---|---|---|
| 57297-765-02 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-06 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-09 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-11 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |
| 57297-765-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e287-f424-e053-dadaa90a57ce | 6e7fb778-6b58-4f34-939c-332fd0f2f9b8 |