Atorvastatin Calcium

Product NDC: 68071-5246
11-digit product format: 680715246
Labeler code: 68071
Product ID: 68071-5246_d772b51b-e29d-38b3-e053-2a95a90aadfd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA091624
Marketing category: ANDA
Marketing start: 2013-04-05
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-5246		D	Discontinued by firm		2026-10-05
excluded package	package	68071-5246	68071-5246-9	D	Discontinued by firm		2026-10-05

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-5246-9	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-5246-9	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68071-5246-9	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68071-5246-9	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A091624-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05
A091624-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05
A091624-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05
A091624-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091624-001	AB
A091624-002	AB
A091624-003	AB
A091624-004	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	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091624-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091624-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091624-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091624-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091624-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091624-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091624-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091624-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091624-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091624-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091624-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091624-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091624-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091624-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091624-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091624-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091624-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091624-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091624-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091624-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091624-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091624-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091624-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091624-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091624-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091624-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091624-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091624-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091624-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091624-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091624-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091624-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091624-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091624-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091624-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091624-004	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5246-9	2022-07-19	C162847	48780-1	d6a99b39-a4c8-a426-e053-dadaa90af4c2	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
68071-5246-9	2022-01-28	C162847	48780-1	d6a99b39-a4c8-a426-e053-dadaa90af4c2	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

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	Marketing end	Sample	Exclude flag	Status
68071-5246-9	68071524609	90 TABLET, FILM COATED in 1 BOTTLE (68071-5246-9)	2020-04-29	0000-00-00	No	No	Current