Amlodipine besylate and Atorvastatin calcium
- Product NDC
- 59762-6710
- 11-digit product format
- 597626710
- Labeler code
- 59762
- Product ID
- 59762-6710_2c4cedeb-fc3c-4ba0-a899-19701dddc1d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate and atorvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Greenstone LLC
- Application
- NDA021540
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-04-04
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 59762-6710 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 59762-6710 | 59762-6710-1 | 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 |
|---|---|---|---|---|---|---|---|
| N021540-001 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-002 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-003 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-004 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-005 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-006 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-007 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 |
| N021540-008 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2004-01-30 |
| N021540-009 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | RLD | 2004-07-29 |
| N021540-010 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | RLD | 2004-07-29 |
| N021540-011 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | RLD | 2004-07-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021540-001 | AB |
| N021540-002 | AB |
| N021540-003 | AB |
| N021540-004 | AB |
| N021540-005 | AB |
| N021540-006 | AB |
| N021540-007 | AB |
| N021540-008 | AB |
| N021540-009 | AB |
| N021540-010 | AB |
| N021540-011 | 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 | N021540-001 | CADUET | EQ 5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-002 | CADUET | EQ 5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-003 | CADUET | EQ 5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-004 | CADUET | EQ 5MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-005 | CADUET | EQ 10MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-006 | CADUET | EQ 10MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-007 | CADUET | EQ 10MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | RLD | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-008 | CADUET | EQ 10MG BASE;EQ 80MG BASE | TABLET / ORAL | AB | RLD, RS | 2004-01-30 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-009 | CADUET | EQ 2.5MG BASE;EQ 10MG BASE | TABLET / ORAL | AB | RLD | 2004-07-29 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-010 | CADUET | EQ 2.5MG BASE;EQ 20MG BASE | TABLET / ORAL | AB | RLD | 2004-07-29 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-011 | CADUET | EQ 2.5MG BASE;EQ 40MG BASE | TABLET / ORAL | AB | RLD | 2004-07-29 | 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 | N021540-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-004 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-005 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-006 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-007 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-008 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-009 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-010 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | N021540-011 | 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 |
|---|---|---|---|---|---|---|
| Caduet | AMLODIPINE AND ATORVASTATIN | Pfizer Laboratories Div Pfizer Inc | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 2026-06-25 | Warnings, Adverse reactions | 021540 NDA021540 |
| Caduet | AMLODIPINE AND ATORVASTATIN | Viatris Specialty LLC | 164394b3-d7ba-4bbf-b64b-e2dd15735ea8 | 2026-06-25 | Warnings, Adverse reactions | 021540 NDA021540 |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Prasco Laboratories | 14124e56-77ba-426d-8f5a-dbe42eda1a20 | 2026-05-21 | Warnings, Adverse reactions | 021540 NDA021540 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-6710-1 | EA - Each | 59762-6710 | bf6d6e56-b3b9-4d6c-914f-c6d445bdaf6b | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59762-6710-1 | 59762671001 | 30 TABLET, FILM COATED in 1 BOTTLE (59762-6710-1) | 2014-04-04 | 0000-00-00 | No | No | Current |