Amlodipine Besylate
- Product NDC
- 0615-7939
- 11-digit product format
- 006157939
- Labeler code
- 0615
- Product ID
- 0615-7939_b1704f51-8080-4f2d-8ef8-1e01464b783c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA077073
- Marketing category
- ANDA
- Marketing start
- 2007-09-26
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0615-7939 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0615-7939 | 0615-7939-05 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-7939 | 0615-7939-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-7939 | 0615-7939-39 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077073-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-09-26 | |
| A077073-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-09-26 | |
| A077073-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-09-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077073-001 | AB |
| A077073-002 | AB |
| A077073-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A077073-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2007-09-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077073-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2007-09-26 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077073-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-09-26 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A077073-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077073-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077073-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NuCare Pharmaceuticals, Inc. | 4926f00c-ee19-3e10-e054-00144ff88e88 | 2026-07-17 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | REMEDYREPACK INC. | d09173a1-5e3c-4c86-8c7c-15238925ef50 | 2026-07-01 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | REMEDYREPACK INC. | a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55 | 2026-06-24 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bryant Ranch Prepack | f546047f-1cc6-4bbe-a67b-b5c9815b89af | 2026-05-22 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 215e0890-0484-45e8-a731-aea53821ad8e | 2026-05-19 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | aec7618e-c9da-431f-8b6a-14aa399242f6 | 2026-02-25 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | PD-Rx Pharmaceuticals, Inc. | e01efe66-2f31-4261-92ca-0b41f27104da | 2026-01-07 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Northwind Health Company, LLC | 0c5784b9-5542-144f-e063-6394a90a7ebc | 2026-01-01 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Northwind Health Company, LLC | 03fe9ad2-3a1a-78db-e063-6294a90a2ed3 | 2026-01-01 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Cipla USA Inc. | 5409b296-3bed-47cd-abba-9fe6f6833af6 | 2025-12-03 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Quallent Pharmaceuticals Health LLC | c262dedb-1d13-4447-9355-f11e1dbbfb4d | 2025-10-13 | Warnings, Adverse reactions | 077073 ANDA077073 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Proficient Rx LP | 410aa0a5-43cf-455c-b51d-7dfbc24eee32 | 2020-02-01 | Warnings, Adverse reactions | 077073 ANDA077073 |