Atorvastatin Calcium

Product NDC: 0378-3953
11-digit product format: 003783953
Labeler code: 0378
Product ID: 0378-3953_c94bf799-ec3d-4644-b1a2-3c7b3f612e19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA091226
Marketing category: ANDA
Marketing start: 2013-09-19
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 package	package	0378-3953	0378-3953-07	D	Discontinued by firm		2026-08-17
excluded package	package	0378-3953	0378-3953-09	D	Discontinued by firm		2026-08-17

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0378-3953-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0378-3953-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0378-3953-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0378-3953-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0378-3953-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0378-3953-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0378-3953-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0378-3953-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0378-3953-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0378-3953-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0378-3953-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0378-3953-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0378-3953-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0378-3953-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0378-3953-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0378-3953-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0378-3953-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0378-3953-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0378-3953-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0378-3953-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0378-3953-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0378-3953-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0378-3953-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0378-3953-07	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091226-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A091226-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A091226-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A091226-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091226-001	AB
A091226-002	AB
A091226-003	AB
A091226-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091226-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091226-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091226-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091226-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091226-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091226-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091226-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091226-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091226-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091226-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091226-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091226-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091226-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atorvastatin Calcium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	80 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1c	Product name	1	20220302
34152997-af0b-acf4-dcaf-37211afe8ca4	Product name	9	20210312
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-3953-05	Atorvastatin Calcium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	27
0378-3953-07	Atorvastatin Calcium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	27
0378-3953-09	Atorvastatin Calcium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	27
0378-3953-77	Atorvastatin Calcium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3953-07	EA - Each	0378-3953	ca69f903-79ed-445b-a7f3-6980ebc55a15	1	2015-10-02
0378-3953-09	EA - Each	0378-3953	0e1c63ae-69e1-4d49-9824-84d973713cd1	1	2015-10-02
0378-3953-77	EA - Each	0378-3953	11de9f0a-fa5b-47f0-ab05-28d77e7b832b	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3953	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	27	Current NDC, Legacy NDC, 4 package rows	20240719_d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	fbd1c5da-67fb-4412-acb5-4d4c74a43654	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	aee307d6-b3fa-424f-8656-1f30ff413e95	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Safecor Health, LLC	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Mylan Institutional Inc.	7c1083b9-7a20-475d-ba12-4f5d0b53e601	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Mylan Pharmaceuticals Inc.	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091226 application number: ANDA091226 ndc (product): 0378-3953

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617312	atorvastatin 10 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617310	atorvastatin 20 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617311	atorvastatin 40 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
259255	atorvastatin 80 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617312	atorvastatin 10 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617310	atorvastatin 20 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617311	atorvastatin 40 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
259255	atorvastatin 80 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617312	atorvastatin 10 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617310	atorvastatin 20 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617311	atorvastatin 40 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
259255	atorvastatin 80 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3953-05	00378395305	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-05)	2014-02-14	0000-00-00	No	No	Current
0378-3953-07	00378395307	500 in 1 BOTTLE, PLASTIC					Historical
0378-3953-09	00378395309	90 in 1 BOTTLE, PLASTIC					Historical
0378-3953-77	00378395377	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-77)	2013-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Mylan Pharmaceuticals Inc.	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	28
Atorvastatin Calcium	Safecor Health, LLC	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	2
Atorvastatin Calcium	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	15
Atorvastatin Calcium	REMEDYREPACK INC.	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	11
Atorvastatin Calcium	Aphena Pharma Solutions - Tennessee, LLC	2020-07-20	HUMAN PRESCRIPTION DRUG LABEL	6