Amlodipine Besylate
- Product NDC
- 0615-8201
- 11-digit product format
- 006158201
- Labeler code
- 0615
- Product ID
- 0615-8201_3bd86769-1b9e-42fd-ab9c-1c67297952bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2014-03-03
- Marketing end
- 2020-10-31
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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. 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 | 0615-8201 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0615-8201 | 0615-8201-05 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-8201 | 0615-8201-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0615-8201 | 0615-8201-39 | 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 |
|---|---|---|---|---|---|---|---|
| A203245-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | |
| A203245-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | |
| A203245-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203245-001 | AB |
| A203245-002 | AB |
| A203245-003 | 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 | A203245-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2013-10-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A203245-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2013-10-21 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A203245-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2013-10-21 | 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 | A203245-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A203245-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A203245-003 | 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 | ST. MARY'S MEDICAL PARK PHARMACY | b2d5cccd-e5ff-2909-e053-2a95a90a9773 | 2026-05-22 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 988e5acb-356e-4116-b6db-ab8468ed7234 | 2026-04-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 743ae641-14e1-456b-80e6-c6f7d621e969 | 2026-01-16 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | 0de6a6d0-a114-e114-e063-6394a90a34dd | 2025-12-26 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 41af64c4-b788-d827-e063-6394a90a9157 | 2025-10-21 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 3e0fbf93-cc64-4fa5-b586-c2020614c884 | 2025-09-03 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Direct_Rx | 0c7d1f99-dfe0-7041-e063-6294a90a9705 | 2025-07-11 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Redpharm Drug | fc61eee9-ee15-9078-e053-6394a90a22f4 | 2025-01-23 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Quality Care Products, LLC | a75e4797-6b7f-4366-9105-79d6877adac5 | 2024-12-19 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 699d3ba2-a342-4e3d-b8ad-c14e0df64dfe | 2024-10-09 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | da4e36d3-1ddc-4350-9a00-86975e523f75 | 2024-10-09 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | b1151904-5085-49bd-94ec-cb2894f4eb10 | 2024-08-22 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | b4cc6d7e-923b-e81c-e053-2995a90a0731 | 2024-07-17 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Direct_Rx | 094498f2-11d9-2a05-e063-6294a90ab2e1 | 2024-06-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5a67bbdc-ac1f-4778-bbdc-929df140b7f5 | 2024-06-10 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 52daa759-3327-461a-8cfc-3c6253df91ec | 2024-03-05 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5c50c3fe-afe5-459e-95c0-c9af4cbb6909 | 2023-11-13 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unichem Pharmaceuticals (USA), Inc. | a516b336-8f60-4b86-8921-c7d6c07629f2 | 2022-12-05 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6 | 2022-04-01 | Warnings, Adverse reactions | 203245 ANDA203245 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | c2c51ec3-ffb0-4240-b048-a8e424775a76 | 2021-08-01 | Warnings, Adverse reactions | 203245 ANDA203245 |