Amlodipine Besylate
- Product NDC
- 68788-1738
- 11-digit product format
- 687881738
- Labeler code
- 68788
- Product ID
- 68788-1738_558333c8-9d13-4dc2-8f8b-d51cded3ec49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2010-04-07
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- 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 | 68788-1738 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-1738 | 68788-1738-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-1738 | 68788-1738-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-1738 | 68788-1738-6 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-1738 | 68788-1738-9 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078414-001 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2010-04-07 | |
| A078414-002 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2010-04-07 | |
| A078414-003 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2010-04-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078414-001 | AB |
| A078414-002 | AB |
| A078414-003 | 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 | A078414-001 | AMLODIPINE BESYLATE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2010-04-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078414-002 | AMLODIPINE BESYLATE | EQ 5MG BASE | TABLET / ORAL | AB | 2010-04-07 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078414-003 | AMLODIPINE BESYLATE | EQ 10MG BASE | TABLET / ORAL | AB | 2010-04-07 | 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 | A078414-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078414-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078414-003 | 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 2.5 mg | AMLODIPINE BESYLATE | PD-Rx Pharmaceuticals, Inc. | 1080fcea-a5da-499d-a855-690c13559071 | 2026-07-17 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 2.5 mg | AMLODIPINE BESYLATE | Oxford Pharmaceuticals, LLC | 6f20efca-943b-4bc2-a157-0931bd4d4585 | 2026-03-28 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE | Preferred Pharmaceuticals Inc. | ea9f44a1-96cf-496a-8c07-18d8de27e512 | 2026-02-25 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 5 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 49104797-8202-1376-e063-6294a90adb38 | 2026-01-23 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 47e494d2-8971-3f8f-e063-6394a90adb20 | 2026-01-08 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 2.5 mg | AMLODIPINE BESYLATE | Proficient Rx LP | 6313edc5-d2d5-44a1-a06f-7f7829c870d2 | 2025-02-01 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 1871ddaf-ed2c-c3ce-e063-6394a90a1bee | 2024-12-20 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 10 mg | AMLODIPINE BESYLATE | NuCare Pharmaceuticals,Inc. | ffe96aa1-db66-33e4-e053-6394a90a7e4e | 2024-03-26 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 2.5 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 132c078d-7d31-a6f2-e063-6294a90af095 | 2024-03-08 | Warnings, Adverse reactions | 078414 ANDA078414 |
| AMLODIPINE BESYLATE 5 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | b597d1e1-aba1-4272-bed7-4c95e8150d58 | 2023-04-19 | Warnings, Adverse reactions | 078414 ANDA078414 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-1738-3 | EA - Each | 68788-1738 | cff044e9-45b2-4009-9a24-c3518c5e023e | 1 | 2015-02-02 |