Atorvastatin Calcium

Product NDC: 72189-557
11-digit product format: 721890557
Labeler code: 72189
Product ID: 72189-557_339eff5f-588e-3a5b-e063-6294a90abed0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_rx
Application: ANDA211933
Marketing category: ANDA
Marketing start: 2024-06-14
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211933-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08
A211933-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08
A211933-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08
A211933-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211933-001	AB
A211933-002	AB
A211933-003	AB
A211933-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211933-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211933-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211933-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211933-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211933-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211933-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211933-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211933-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211933-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211933-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211933-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211933-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211933-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211933-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211933-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211933-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211933-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211933-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	40 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
617311	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
1ade00fd-5eb4-f67a-e063-6294a90a9112	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-557-30	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
72189-557-90	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-557-30	EA - Each	72189-557	44b9b532-b78f-474d-8938-78e88f4a5794	1	2025-05-14
72189-557-90	EA - Each	72189-557	bde8b2d0-60e6-43cb-a648-0e1afdd4abcc	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-557	ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECT_RX]	2	Current NDC, 2 package rows	20250427_1ade00fd-5eb4-f67a-e063-6294a90a9112.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	8d5b85cf-d8a0-e4d7-e053-2a95a90aad67	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Novadoz Pharmaceuticals LLC	bc448f40-421c-490f-8c39-fa8135507973	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	498ef8e6-3366-42f4-99fe-b3e1dedae887	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	d97df6ad-87ca-46ec-8de7-4a958ab3b463	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	01eadde8-37f3-4474-995f-22c1a65adf12	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933
Atorvastatin calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	514fcba1-713c-4aeb-be8c-369fcf9b4ffe	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211933 application number: ANDA211933

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
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	1ade00fd-5eb4-f67a-e063-6294a90a9112	2
617311	atorvastatin 40 MG Oral Tablet	SCD	1ade00fd-5eb4-f67a-e063-6294a90a9112	2
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	1ade00fd-5eb4-f67a-e063-6294a90a9112	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-557-30	72189055730	30 TABLET, FILM COATED in 1 BOTTLE (72189-557-30)	2024-06-14	No	No	Current
72189-557-90	72189055790	90 TABLET, FILM COATED in 1 BOTTLE (72189-557-90)	2024-06-14	No	No	Current