Amlodipine Besylate
- Product NDC
- 63629-7640
- Requested package NDC
- 63629-7640-6
- 11-digit product format
- 636297640
- Labeler code
- 63629
- Product ID
- 63629-7640_716bd50c-fd0f-4022-b049-0d194f3dddb7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 63629-7640 | 63629-7640-6 | 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 |
|---|---|---|---|---|---|---|---|
| A078925-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | |
| A078925-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | |
| A078925-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078925-001 | AB |
| A078925-002 | AB |
| A078925-003 | 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 | A078925-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2009-05-04 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078925-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2009-05-04 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078925-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2009-05-04 | 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 | A078925-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078925-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078925-003 | 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 | REMEDYREPACK INC. | 58a67272-c4c7-4e2c-85a5-9d39034d12c3 | 2026-07-27 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 4ad016ec-e158-4325-9f45-4460cf78dd98 | 2026-07-16 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unit Dose Solutions, Inc. | 5467eee5-1519-7859-e063-6294a90afed1 | 2026-06-16 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 61cb7f91-d1f6-40bd-98a3-c461098a20d9 | 2026-06-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | 6efc0ef6-0424-44fc-a9ea-eb30c3b83239 | 2026-05-28 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Coupler LLC | 2904c6e1-2c51-8035-e063-6294a90aa04b | 2026-05-13 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 72dafc2f-5266-442b-914a-61d1ef1f7ab8 | 2026-04-29 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | d2f66b58-78ec-456b-8397-2120a223827c | 2026-04-28 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | cd305e6e-9107-4d25-9918-8d0d9b9ba1ca | 2026-04-24 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 50204e86-a345-4d2f-b62f-a548787e197f | 2026-04-24 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals, Inc. | 01139e81-a4fa-4e13-acdf-c75c79a1aa9c | 2026-02-23 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 1ff04bd2-9926-48a4-9afc-eab0789dba01 | 2026-02-23 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 204f27e9-5041-4677-b313-866ca69abad9 | 2026-02-13 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | 6e038d92-09f3-4517-947e-146d007114b8 | 2026-01-14 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | f2b8274b-d849-6793-e053-2a95a90aa0e8 | 2026-01-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Northwind Health Company, LLC | f32bb322-68d7-a4ca-e053-2995a90aa7b0 | 2026-01-01 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Ascend Laboratories, LLC | 2b0bcb95-dc85-46f7-8b69-ca55cd58b30e | 2025-12-10 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | QPharma Inc | 3f74ed2b-4712-4026-ac2c-9239a211dde3 | 2025-12-05 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | PD-Rx Pharmaceuticals, Inc. | 47114f60-4151-43d4-ac2d-adc49492a679 | 2025-10-15 | Warnings, Adverse reactions | 078925 ANDA078925 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | PD-Rx Pharmaceuticals, Inc. | ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608 | 2025-10-15 | Warnings, Adverse reactions | 078925 ANDA078925 |
FDA-Initiated Inactive NDC Indexing#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-7640-6 | 63629764006 | 800 TABLET in 1 BOTTLE (63629-7640-6) | 800 tablet | 2014-04-17 | 0000-00-00 | No | No | Current |