Atorvastatin Calcium

Product NDC: 50090-5639
11-digit product format: 500905639
Labeler code: 50090
Product ID: 50090-5639_009cb8fd-a8d5-43b1-98ab-8cb00dc19649
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA204991
Marketing category: ANDA
Marketing start: 2020-09-24
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-5639		D	Discontinued by firm	2026-08-17
excluded package	package	50090-5639	50090-5639-0	D	Discontinued by firm	2026-08-17
excluded package	package	50090-5639	50090-5639-1	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 · 6 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	50090-5639-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5639-0	`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	50090-5639-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5639-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	Approval date
A204991-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06
A204991-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06
A204991-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06
A204991-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-003	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204991-004	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-003	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204991-004	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204991-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204991-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204991-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204991-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204991-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204991-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204991-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204991-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204991-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204991-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204991-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204991-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204991-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204991-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204991-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204991-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204991-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204991-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204991-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204991-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204991-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204991-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204991-004	AB	1	`87673890dc5c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5639-0	2023-02-06	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
50090-5639-1	2023-02-06	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
50090-5639-0	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
50090-5639-1	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5639-0	EA - Each	50090-5639	39eabc2d-701b-4af2-bcd2-dcf03eabc2a9	1	2022-10-06
50090-5639-1	EA - Each	50090-5639	10d7fff1-acfd-4571-ae22-c9bc2b500ddd	1	2022-10-06

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	c3b70f79-45a3-0869-e053-2a95a90a3cdb	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	5868d3c2-ae17-4a7e-9580-7c3cf9bf009e	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Lupin Pharmaceuticals, Inc.	a5767370-15a2-45e5-b980-7af9523aea7b	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	85c38e0b-3d0b-4b04-990a-ed077a4c43e4	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	d3f27113-785c-419e-955a-d6782fade438	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	f4154300-65d4-4e31-97ad-b8d086c676e2	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204991 application number: ANDA204991

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5639-0	50090563900	30 TABLET in 1 BOTTLE (50090-5639-0)	30 tablet	2021-09-03	0000-00-00	No	No	Current
50090-5639-1	50090563901	90 TABLET in 1 BOTTLE (50090-5639-1)	90 tablet	2021-09-03	0000-00-00	No	No	Current