Caduet
- Product NDC
- 0069-6565
- 11-digit product format
- 000696565
- Labeler code
- 0069
- Product ID
- 0069-6565_f7f456e3-dc8d-4266-bc71-52ea64c2f270
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine and atorvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA021540
- Marketing category
- NDA
- Marketing start
- 2022-08-31
- Substance
- AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
- Active strength
- 5; 40 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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
- 2027-12-31
- Current FDA listing
- Yes
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 0069-6565 |
| 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 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Caduet
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| ATORVASTATIN CALCIUM TRIHYDRATE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 864V2Q084H | Internal UNII lookup |
| 48A5M73Z4Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 404011 | Internal RxNorm lookup |
| 404013 | Internal RxNorm lookup |
| 597967 | Internal RxNorm lookup |
| 597977 | Internal RxNorm lookup |
| 597980 | Internal RxNorm lookup |
| 597984 | Internal RxNorm lookup |
| 597987 | Internal RxNorm lookup |
| 597990 | Internal RxNorm lookup |
| 750199 | Internal RxNorm lookup |
| 750203 | Internal RxNorm lookup |
| 750207 | Internal RxNorm lookup |
| 750211 | Internal RxNorm lookup |
| 750227 | Internal RxNorm lookup |
| 750231 | Internal RxNorm lookup |
| 750235 | Internal RxNorm lookup |
| 750239 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0069-6565-30 | Caduet | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 51 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0069-6565-30 | EA - Each | 0069-6565 | f477a601-3041-4f84-9399-4ba4732be0ac | 1 | 2023-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0069-6565 | CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED CADUET (AMLODIPINE AND ATORVASTATIN) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 50 | Current NDC, Legacy NDC, 1 package rows | 20250305_6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 597987 | amLODIPine besylate 10 MG / atorvastatin calcium 10 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597967 | amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597990 | amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 404013 | amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597977 | amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597980 | amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597984 | amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 404011 | amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750199 | Caduet 10 MG / 10 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750203 | Caduet 10 MG / 20 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750207 | Caduet 10 MG / 40 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750211 | Caduet 10 MG / 80 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750227 | Caduet 5 MG / 10 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750231 | Caduet 5 MG / 20 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750235 | Caduet 5 MG / 40 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750239 | Caduet 5 MG / 80 MG Oral Tablet | PSN | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750199 | amlodipine 10 MG / atorvastatin 10 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750203 | amlodipine 10 MG / atorvastatin 20 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750207 | amlodipine 10 MG / atorvastatin 40 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750211 | amlodipine 10 MG / atorvastatin 80 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750227 | amlodipine 5 MG / atorvastatin 10 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750231 | amlodipine 5 MG / atorvastatin 20 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750235 | amlodipine 5 MG / atorvastatin 40 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750239 | amlodipine 5 MG / atorvastatin 80 MG Oral Tablet [Caduet] | SBD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597987 | amlodipine 10 MG / atorvastatin 10 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597967 | amlodipine 10 MG / atorvastatin 20 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597990 | amlodipine 10 MG / atorvastatin 40 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 404013 | amlodipine 10 MG / atorvastatin 80 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597977 | amlodipine 5 MG / atorvastatin 10 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597980 | amlodipine 5 MG / atorvastatin 20 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597984 | amlodipine 5 MG / atorvastatin 40 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 404011 | amlodipine 5 MG / atorvastatin 80 MG Oral Tablet | SCD | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597987 | amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597967 | amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597990 | amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 404013 | amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597977 | amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597980 | amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 597984 | amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 404011 | amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750199 | Caduet 10/10 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750203 | Caduet 10/20 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750207 | Caduet 10/40 MG Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750211 | Caduet 10/80 (amlodipine / atorvastatin) Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750211 | Caduet 10/80 Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750227 | Caduet 5/10 (amlodipine / atorvastatin) Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750227 | Caduet 5/10 Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750231 | Caduet 5/20 (amlodipine / atorvastatin) Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750231 | Caduet 5/20 Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750235 | Caduet 5/40 (amlodipine / atorvastatin) Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750235 | Caduet 5/40 Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750239 | Caduet 5/80 (amlodipine / atorvastatin) Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
| 750239 | Caduet 5/80 Oral Tablet | SY | 6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6 | 51 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0069-6565-30 | 00069656530 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-6565-30) | 2022-08-31 | 0000-00-00 | No | No | Current |