Amlodipine Besylate
- Product NDC
- 51079-451
- 11-digit product format
- 510790451
- Labeler code
- 51079
- Product ID
- 51079-451_7b2018ec-84d3-6b95-e053-2a91aa0a2626
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA076418
- Marketing category
- ANDA
- Marketing start
- 2007-04-02
- Marketing end
- 2019-11-30
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 51079-451 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 51079-451 | 51079-451-20 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 51079-451 | 51079-451-56 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A076418-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | | | 2005-10-03 |
| A076418-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | | | 2005-10-03 |
| A076418-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | | | 2005-10-03 |
DailyMed Socrata Ingredients#