ATORVASTATIN CALCIUM

Product NDC: 72189-226
11-digit product format: 721890226
Labeler code: 72189
Product ID: 72189-226_2c283f9f-1dbb-4a4c-e063-6394a90a7953
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA076477
Marketing category: ANDA
Marketing start: 2021-06-01
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: 2026-12-31
Current FDA listing: Yes

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
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-226-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-226-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-226-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-226-30	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A076477-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2011-11-30
A076477-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2011-11-30
A076477-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2011-11-30
A076477-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2011-11-30

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	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`

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
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076477-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-004	AB	1	`1e350fbaab3a…`

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	10 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
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
c3b70f79-45a3-0869-e053-2a95a90a3cdb	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-226-30	ATORVASTATIN CALCIUM	30 in 1 BOTTLE	TABLET, FILM COATED	30		4
72189-226-90	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-226-30	EA - Each	72189-226	7086b2eb-ce33-400c-807e-f13ec2e98fdc	1	2021-12-08
72189-226-90	EA - Each	72189-226	8887cb35-57e9-44b4-8333-6c35b3385239	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-226	ATORVASTATIN CALCIUM TABLET, FILM COATED ATORVASTATIN CALCIUM TABLET [DIRECT RX]	4	Current NDC, Legacy NDC, 2 package rows	20250121_c3b70f79-45a3-0869-e053-2a95a90a3cdb.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Sun Pharmaceutical Industries Inc.	595ab888-6b55-4642-a32f-e8521821ed81	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	49dcc58a-9f23-045d-e063-6394a90abda6	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	c3b70f79-45a3-0869-e053-2a95a90a3cdb	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477 ndc (product): 72189-226
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f7af3b3a-b73e-41ee-80e3-2be036672bb7	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b1a840cf-47aa-b931-e053-2a95a90a1047	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	d77e155c-403d-449e-bafd-11c9bd4974dd	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477

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	c3b70f79-45a3-0869-e053-2a95a90a3cdb	4
617312	atorvastatin 10 MG Oral Tablet	SCD	c3b70f79-45a3-0869-e053-2a95a90a3cdb	4
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	c3b70f79-45a3-0869-e053-2a95a90a3cdb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-226-30	72189022630	30 TABLET, FILM COATED in 1 BOTTLE (72189-226-30)	2021-06-01	0000-00-00	No	No	Current
72189-226-90	72189022690	90 TABLET, FILM COATED in 1 BOTTLE (72189-226-90)	2021-06-01	0000-00-00	No	No	Current