Atorvastatin calcium

Product NDC: 68071-4979
11-digit product format: 680714979
Labeler code: 68071
Product ID: 68071-4979_bbb2e2d4-f3f3-6f1b-e053-2a95a90ae970
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA211933
Marketing category: ANDA
Marketing start: 2019-02-08
Marketing end: 0000-00-00
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: 2022-12-31
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	68071-4979		D	Discontinued by firm		2026-08-03
excluded package	package	68071-4979	68071-4979-6	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-4979-6	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-4979-6	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-4979-6	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-4979-6	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-4979-6	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-4979-6	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-4979-6	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-4979-6	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-4979-6	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-4979-6	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-4979-6	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-4979-6	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4979-6	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4979-6	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4979-6	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A211933-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08
A211933-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08
A211933-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08
A211933-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211933-001	AB
A211933-002	AB
A211933-003	AB
A211933-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A211933-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211933-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211933-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211933-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211933-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211933-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211933-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-18	These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
2023-01-30	These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
2021-02-19	These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
2021-01-29	These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	52f99e39-fb92-e9f5-e063-6294a90a1b6a	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	5b3c3043-9af6-48eb-8b10-528e58c88e48	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	51e24220-3374-4e5e-9a8d-4113002c5bed	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	b0bbab86-6789-4ffb-8f84-ee91b69fdb34	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	9786388d-ac8d-4646-9fe4-b33e8fda86b2	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	e78ba844-97a6-4602-92b6-8190028b826d	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	bf35034d-27ab-4263-a9ed-c7cee1a4fb0a	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	21234914-e1bb-4118-8f81-4ab4a59e9e1e	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	124c111c-9272-eca9-e063-6394a90a0ad5	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	13b1578a-70cc-6c58-e063-6394a90a0d1b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	ec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f1f3e4e0-5407-4831-9885-3a37e72356c0	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	4509aa67-06d4-41d1-80b6-c9bd8ad0bf07	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	46eeb12f-7e38-4828-b7d1-26b6155bc64a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	e959b07b-3e6c-44cc-9a6d-c6689d393e4c	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	00afce9b-48c9-487a-a738-e359c005c707	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	4ff0d618-cde4-49ae-8bcb-98dafc3ecdba	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_rx	1ade00fd-5eb4-f67a-e063-6294a90a9112	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	9168df23-4260-46be-9556-8b037af0ea28	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b490414a-35e7-fded-e053-2a95a90aca8d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
68071-4979-6	68071497906	60 TABLET, FILM COATED in 1 BOTTLE (68071-4979-6)	2019-07-24	0000-00-00	No	No	Current