Caduet

Product NDC: 0069-2960
11-digit product format: 000692960
Labeler code: 0069
Product ID: 0069-2960_0e382b35-5cf0-4f78-9558-a8dda50584e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate and atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA021540
Marketing category: NDA
Marketing start: 2004-01-30
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: 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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0069-2960		D	Discontinued by firm		2026-07-31
excluded package	package	0069-2960	0069-2960-30	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 11 matching rows.

Application-product, TE code table
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 table
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 table
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.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 021540 application number: NDA021540
Caduet	AMLODIPINE AND ATORVASTATIN	Viatris Specialty LLC	164394b3-d7ba-4bbf-b64b-e2dd15735ea8	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021540 application number: NDA021540
Amlodipine and Atorvastatin	AMLODIPINE AND ATORVASTATIN	Prasco Laboratories	14124e56-77ba-426d-8f5a-dbe42eda1a20	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021540 application number: NDA021540

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-2960-30	EA - Each	0069-2960	98a71f5e-f07b-407f-80c6-60d9823a63cf	1	2012-07-24

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE