Amlodipine Besylate
- Product NDC
- 0378-5209
- 11-digit product format
- 003785209
- Labeler code
- 0378
- Product ID
- 0378-5209_2bca2c4d-60f5-438a-951c-c9ef69f98d48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076418
- Marketing category
- ANDA
- Marketing start
- 2005-10-03
- 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 | 0378-5209 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-5209 | 0378-5209-05 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-5209 | 0378-5209-77 | 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#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | |
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |