Atorvastatin Calcium

Product NDC: 50090-5634
11-digit product format: 500905634
Labeler code: 50090
Product ID: 50090-5634_25b440e3-4eff-4c68-bd46-78d143e3ae55
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
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 20 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

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	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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-10-29 15:01 UTC	2024-10	A204991-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204991-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204991-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204991-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2019-03-06	`d06236e962d9…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atorvastatin Calcium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48A5M73Z4Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617310	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d3f27113-785c-419e-955a-d6782fade438	Available on FDA.report

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, Related label table
NDC	Effective	Related label
50090-5634-0	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
50090-5634-1	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
50090-5634-0	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
50090-5634-1	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5634-0	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET	30		3
50090-5634-1	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5634-0	EA - Each	50090-5634	803e0b8b-615b-4755-9e4b-b0f01b388a41	1	2022-10-06
50090-5634-1	EA - Each	50090-5634	e494b1f9-d9e5-44e6-911a-1f8f1d01ea14	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5634	ATORVASTATIN CALCIUM TABLET [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 2 package rows	20230208_d3f27113-785c-419e-955a-d6782fade438.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 · 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 ndc (product): 50090-5634
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	d3f27113-785c-419e-955a-d6782fade438	3
617310	atorvastatin 20 MG Oral Tablet	SCD	d3f27113-785c-419e-955a-d6782fade438	3
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	d3f27113-785c-419e-955a-d6782fade438	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5634-0	50090563400	30 TABLET in 1 BOTTLE (50090-5634-0)	30 tablet	2021-09-03	0000-00-00	No	No	Current
50090-5634-1	50090563401	90 TABLET in 1 BOTTLE (50090-5634-1)	90 tablet	2021-09-09	0000-00-00	No	No	Current