ATORVASTATIN CALCIUM

Product NDC: 50090-4964
Requested package NDC: 50090-4964-1
11-digit product format: 500904964
Labeler code: 50090
Product ID: 50090-4964_9c41ec2b-7882-4243-9a70-342ea0005faa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA205945
Marketing category: ANDA
Marketing start: 2020-01-01
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4964	50090-4964-1	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A205945-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07
A205945-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07
A205945-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07
A205945-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205945-001	AB
A205945-002	AB
A205945-003	AB
A205945-004	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 4 · 156 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	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205945-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-11-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	A205945-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205945-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205945-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205945-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205945-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205945-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205945-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205945-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205945-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205945-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205945-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205945-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205945-004	AB	1	`d06236e962d9…`

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
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4964-0	2023-01-30	C162847	48780-1	f386c649-dcd2-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1996
50090-4964-1	2023-01-30	C162847	48780-1	f386c649-dcd2-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4964-0	ATORVASTATIN CALCIUM	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
50090-4964-1	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4964-1	EA - Each	50090-4964	d97ca04b-0dfe-4295-8f21-8efc1206104a	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4964	ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20210417_fe2451d1-a826-4bed-85d9-d80d1fac3d25.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Micro Labs Limited	2e94161c-3360-4fb0-bb3a-048fdc1d137a	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205945 application number: ANDA205945
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Coupler LLC	2d93e3c4-59cc-cff4-e063-6394a90a8f7f	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205945 application number: ANDA205945

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	fe2451d1-a826-4bed-85d9-d80d1fac3d25	3
617312	atorvastatin 10 MG Oral Tablet	SCD	fe2451d1-a826-4bed-85d9-d80d1fac3d25	3
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	fe2451d1-a826-4bed-85d9-d80d1fac3d25	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4964-1	50090496401	90 TABLET, FILM COATED in 1 BOTTLE (50090-4964-1)	2020-03-16	0000-00-00	No	No	Current