Amlodipine besylate and Atorvastatin calcium

Product NDC: 59762-6730
11-digit product format: 597626730
Labeler code: 59762
Product ID: 59762-6730_2b7f54ab-bd35-461c-852a-7041efb60fcd
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: 10 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	59762-6730		D	Discontinued by firm		2026-08-03
excluded package	package	59762-6730	59762-6730-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59762-6730-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59762-6730-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59762-6730-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59762-6730-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59762-6730-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59762-6730-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59762-6730-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59762-6730-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59762-6730-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59762-6730-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59762-6730-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59762-6730-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Product history page 1 of 12 · 451 observed 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
2026-02-19 14:30 UTC	2026-02	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-008	CADUET	EQ 10MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2004-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-009	CADUET	EQ 2.5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-010	CADUET	EQ 2.5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-011	CADUET	EQ 2.5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-001	CADUET	EQ 5MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-002	CADUET	EQ 5MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-003	CADUET	EQ 5MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-004	CADUET	EQ 5MG BASE;EQ 80MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-005	CADUET	EQ 10MG BASE;EQ 10MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-006	CADUET	EQ 10MG BASE;EQ 20MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-007	CADUET	EQ 10MG BASE;EQ 40MG BASE	TABLET / ORAL	AB	RLD	2004-01-30	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 12 · 451 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021540-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-008	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-009	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-010	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021540-011	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-008	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-009	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-010	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021540-011	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021540-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-008	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-009	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-010	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021540-011	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021540-007	AB	1	`fd3edfee7708…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-6730-1	EA - Each	59762-6730	d305dea8-b2dd-40dc-8cb2-d4c531bb14a9	1	2014-05-02
59762-6730-5	EA - Each	59762-6730	c8096104-70c3-411e-936b-4d4852f00eb5	1	2014-05-02
59762-6730-7	EA - Each	59762-6730	c10fe7f9-34fb-486f-8b7f-9ca3545d936b	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [GREENSTONE LLC]	10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-6730-1	59762673001	30 TABLET, FILM COATED in 1 BOTTLE (59762-6730-1)	2014-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine besylate and Atorvastatin calcium	Greenstone LLC \| Pfizer Inc \| Pharmacia & Upjohn Company LLC \| Pfizer Ireland Pharmaceuticals \| Pfizer Manufacturing Deutschland GmbH	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	26