Atorvastatin Calcium

Product NDC: 72189-531
11-digit product format: 721890531
Labeler code: 72189
Product ID: 72189-531_4c5d2d2b-9b9d-3a37-e063-6294a90a4137
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA213853
Marketing category: ANDA
Marketing start: 2024-01-04
Substance: ATORVASTATIN
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	TE codes	Approval date
A213853-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-19
A213853-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-19
A213853-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2020-08-19
A213853-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2020-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213853-001	AB
A213853-002	AB
A213853-003	AB
A213853-004	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 · 148 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	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213853-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	BX	2020-08-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A213853-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213853-004	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213853-004	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213853-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213853-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213853-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213853-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213853-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213853-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213853-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213853-004	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213853-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-003	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213853-004	BX	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atorvastatin Calcium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
A0JWA85V8F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617312	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
0e24e7cb-1949-6686-e063-6394a90a4760	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-531-30	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET	30		2
72189-531-90	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-531-90	EA - Each	72189-531	358e44df-9a7b-4d4e-828a-e5e339f4639e	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-531	ATORVASTATIN CALCIUM TABLET [DIRECT_RX]	1	Current NDC, 2 package rows	20240106_0e24e7cb-1949-6686-e063-6394a90a4760.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	6600f22e-d303-4fe3-8212-accd6fb06e62	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	8821431a-c387-4b75-9540-f92bd455e961	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	20f820ba-9600-4b51-bf23-8c99e815674c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	112ae40c-b612-405b-8f68-6d4bf09f9440	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	0e24e7cb-1949-6686-e063-6394a90a4760	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853 ndc (product): 72189-531
Atorvastatin calcium	ATORVASTATIN CALCIUM	Umedica Laboratories USA Inc.	5a7594ca-30be-4350-827f-ef745a2a7e18	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	NIVAGEN PHARMACEUTICALS, INC.	7c58bf4a-4a92-4db8-89bc-4de1b5831efc	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	604a011e-6c64-4895-8f6e-d28f119c4c22	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	71cd9b85-4914-4b0b-97db-7aaf25983211	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DirectRX	d076309f-313a-1c71-e053-2995a90a7bb7	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	f7e8c8d2-b74e-6afd-e053-6394a90af83e	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853
Atorvastatin calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	acbbd2c4-60bd-4e01-ad7a-b9b3178569f0	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213853 application number: ANDA213853

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A0JWA85V8F	ATORVASTATIN	134523-00-5	ATORVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	0e24e7cb-1949-6686-e063-6394a90a4760	2
617312	atorvastatin 10 MG Oral Tablet	SCD	0e24e7cb-1949-6686-e063-6394a90a4760	2
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	0e24e7cb-1949-6686-e063-6394a90a4760	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-531-30	72189053130	30 TABLET in 1 BOTTLE (72189-531-30)	30 tablet	2024-01-04	No	No	Current
72189-531-90	72189053190	90 TABLET in 1 BOTTLE (72189-531-90)	90 tablet	2024-01-04	No	No	Current