Amlodipine Besylate
- Product NDC
- 55154-5692
- 11-digit product format
- 551545692
- Labeler code
- 55154
- Product ID
- 55154-5692_25046804-2df5-4d59-98a5-ee6d81706922
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health
- Application
- ANDA076418
- Marketing category
- ANDA
- Marketing start
- 2010-01-14
- Marketing end
- 2020-08-31
- 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 | 55154-5692 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 55154-5692 | 55154-5692-0 | 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#