Atorvastatin Calcium

Product NDC: 72189-681
11-digit product format: 721890681
Labeler code: 72189
Product ID: 72189-681_56a9e58f-567f-30cc-e063-6294a90a290f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA217081
Marketing category: ANDA
Marketing start: 2026-07-15
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: 2027-12-31
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
A217081-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05
A217081-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05
A217081-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05
A217081-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217081-001	AB
A217081-002	AB
A217081-003	AB
A217081-004	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 2 · 76 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	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2024-01-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A217081-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217081-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217081-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217081-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217081-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217081-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217081-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217081-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217081-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217081-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217081-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217081-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217081-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217081-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217081-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217081-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217081-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217081-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217081-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217081-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217081-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217081-004	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: 2027-12-31

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
56a9e58f-567e-30cc-e063-6294a90a290f	Available on FDA.report

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin calcium	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	2e20a00c-b373-3a8c-e063-6294a90a637b	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	56a9e58f-567e-30cc-e063-6294a90a290f	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081 ndc (product): 72189-681
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	bd26679f-f8ff-41d2-a384-bd1f66f8a614	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	8cc6240a-58d3-4bca-aa1e-662228957f75	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	f7bb4aac-f716-4dd9-a6d7-6f37e865b843	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	4847b761-30a5-0a1a-e063-6294a90ad02b	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	Coupler LLC	3eee2ddb-851e-15ad-e063-6394a90a173a	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	NorthStar RxLLC	85fbaf22-017b-4163-b33e-c6594994859b	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	ST. MARY'S MEDICAL PARK PHARMACY	31ccef91-ca32-61be-e063-6394a90a1065	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	Coupler LLC	2fffae44-e536-9645-e063-6394a90a7ce5	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	Coupler LLC	2cd9999b-e18f-09de-e063-6294a90a108b	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	Coupler LLC	2c67a15c-53b7-f431-e063-6394a90acc50	2025-01-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081
Atorvastatin calcium	ATORVASTATIN CALCIUM	Lifestar Pharma LLC	de8f2c55-44d2-4e01-b7f2-dfb24f1f8760	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217081 application number: ANDA217081

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	Marketing start	Sample	Exclude flag	Status
72189-681-30	72189068130	30 TABLET, FILM COATED in 1 BOTTLE (72189-681-30)	2026-07-15	No	No	Current