Atorvastatin calcium

Product NDC: 82239-002
11-digit product format: 822390002
Labeler code: 82239
Product ID: 82239-002_803b7d6f-faea-4a13-a141-f2c44d7fca72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin calcium tablets
Dosage form: TABLET
Route: ORAL
Labeler: August Pharmaceutical, LLC
Application: ANDA214969
Marketing category: ANDA
Marketing start: 2021-09-11
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: 2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	82239-002		I	Inactivated by FDA	2026-10-12
excluded package	package	82239-002	82239-002-01	I	Inactivated by FDA	2026-10-12
excluded package	package	82239-002	82239-002-02	I	Inactivated by FDA	2026-10-12
excluded package	package	82239-002	82239-002-03	I	Inactivated by FDA	2026-10-12
excluded package	package	82239-002	82239-002-04	I	Inactivated by FDA	2026-10-12

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 2 · 75 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82239-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82239-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82239-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82239-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82239-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82239-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82239-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82239-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82239-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82239-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82239-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82239-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82239-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82239-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82239-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82239-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82239-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82239-002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82239-002-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82239-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82239-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82239-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82239-002-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82239-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82239-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82239-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82239-002-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82239-002-03	`302b2466d912…`	`e7b80fea0513…`
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	82239-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82239-002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82239-002-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82239-002-03	`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	82239-002-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82239-002-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82239-002-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82239-002-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82239-002-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82239-002-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82239-002-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82239-002-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82239-002-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82239-002-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82239-002-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82239-002-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82239-002-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82239-002-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82239-002-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82239-002-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A214969-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02
A214969-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02
A214969-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02
A214969-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214969-001	AB
A214969-002	AB
A214969-003	AB
A214969-004	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 · 140 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	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2021-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2021-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2021-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2021-09-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A214969-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214969-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214969-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214969-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214969-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214969-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214969-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214969-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214969-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214969-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214969-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214969-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214969-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214969-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214969-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214969-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214969-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214969-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214969-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214969-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214969-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214969-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
03fb3cda-d60a-4873-94e9-6fa77cfb1a1c	Product name	1	20220302
34152997-af0b-acf4-dcaf-37211afe8ca4	Product name	9	20210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
82239-002-01	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
82239-002-02	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
82239-002-03	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
82239-002-04	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82239-002-01	Atorvastatin calcium	30 in 1 BOTTLE	TABLET	30	1
82239-002-02	Atorvastatin calcium	90 in 1 BOTTLE	TABLET	90	1
82239-002-03	Atorvastatin calcium	500 in 1 BOTTLE	TABLET	500	1
82239-002-04	Atorvastatin calcium	1000 in 1 BOTTLE	TABLET	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82239-002	ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM TABLETS) TABLET [AUGUST PHARMACEUTICAL, LLC]	1	Legacy NDC, 4 package rows	20210915_803b7d6f-faea-4a13-a141-f2c44d7fca72.zip

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	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617312	atorvastatin 10 MG Oral Tablet	SCD	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617310	atorvastatin 20 MG Oral Tablet	SCD	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617311	atorvastatin 40 MG Oral Tablet	SCD	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
259255	atorvastatin 80 MG Oral Tablet	SCD	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	803b7d6f-faea-4a13-a141-f2c44d7fca72	1
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	803b7d6f-faea-4a13-a141-f2c44d7fca72	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82239-002-01	82239000201	30 TABLET in 1 BOTTLE (82239-002-01)	30 tablet	2021-09-11	0000-00-00	No	No	Current
82239-002-02	82239000202	90 TABLET in 1 BOTTLE (82239-002-02)	90 tablet	2021-09-11	0000-00-00	No	No	Current
82239-002-03	82239000203	500 TABLET in 1 BOTTLE (82239-002-03)	500 tablet	2021-09-11	0000-00-00	No	No	Current
82239-002-04	82239000204	1000 TABLET in 1 BOTTLE (82239-002-04)	1000 tablet	2021-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin calcium tablets	August Pharmaceutical, LLC \| Halo Pharmaceutical Canada, Inc	2021-09-11	Human Prescription Drug Label	1