Atorvastatin Calcium

Product NDC: 0615-7772
11-digit product format: 006157772
Labeler code: 0615
Product ID: 0615-7772_438c5c78-d15c-4b74-abbc-7485aba00c69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA202357
Marketing category: ANDA
Marketing start: 2012-07-17
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 80 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0615-7772		D	Discontinued by firm	2026-10-05
excluded package	package	0615-7772	0615-7772-05	D	Discontinued by firm	2026-10-05
excluded package	package	0615-7772	0615-7772-39	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 · 45 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	0615-7772-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7772-05	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	0615-7772-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7772-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7772-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7772-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7772-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7772-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7772-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7772-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7772-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7772-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7772-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7772-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7772-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7772-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7772-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7772-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7772-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7772-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7772-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7772-05	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7772-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7772-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7772-05	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7772-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7772-05	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7772-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7772-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7772-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202357-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB		2012-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202357-001	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 · 43 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	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202357-001	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-07-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A202357-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202357-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202357-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202357-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202357-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202357-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202357-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202357-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202357-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202357-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202357-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202357-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202357-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202357-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202357-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202357-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202357-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202357-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202357-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202357-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202357-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202357-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202357-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202357-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202357-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202357-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202357-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202357-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202357-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202357-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202357-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202357-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202357-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202357-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202357-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202357-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202357-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202357-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202357-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202357-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0615-7772-05	2021-03-05	These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
0615-7772-39	2021-03-05	These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
0615-7772-05	2020-01-31	These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
0615-7772-39	2020-01-31	These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Limited	6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d	2020-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202357 application number: ANDA202357

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-26	HUMAN PRESCRIPTION DRUG LABEL	6