Atorvastatin Calcium

Product NDC: 43353-182
Requested package NDC: 43353-182-45
11-digit product format: 433530182
Labeler code: 43353
Product ID: 43353-182_751b826c-7e98-4ffc-8dd0-d4bb32d6fded
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA091226
Marketing category: ANDA
Marketing start: 2013-09-19
Marketing end: 2021-02-28
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-182	43353-182-45	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 · 12 matching rows.

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

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

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
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 · 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	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…`
2024-10-29 15:01 UTC	2024-10	A091226-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091226-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091226-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091226-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`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	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…`
2024-10-29 15:01 UTC	2024-10	A091226-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091226-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091226-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091226-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-182-15	EA - Each	43353-182	bf879b52-52d7-4323-9210-1a02398740af	1	2016-11-08
43353-182-30	EA - Each	43353-182	36f6b3ba-0a1b-4757-9f87-46466f460f89	1	2017-11-06
43353-182-45	EA - Each	43353-182	d811117e-2627-4fbd-bff8-f793b69b87c0	1	2016-11-08
43353-182-60	EA - Each	43353-182	cde336d2-04bc-42f7-92a8-34f61d057852	1	2020-08-06

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

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
43353-182-45	43353018245	45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-182-45)	2016-06-02	2021-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Aphena Pharma Solutions - Tennessee, LLC	2020-07-20	HUMAN PRESCRIPTION DRUG LABEL	6