Atorvastatin Calcium

Product NDC: 0781-5381
11-digit product format: 007815381
Labeler code: 0781
Product ID: 0781-5381_0810bbbb-d9a2-4ed1-8bb3-38329d31c805
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA077575
Marketing category: ANDA
Marketing start: 2012-05-29
Marketing end: 0000-00-00
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: 2021-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-5381		D	Discontinued by firm	2026-10-05
excluded package	package	0781-5381	0781-5381-01	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5381	0781-5381-10	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5381	0781-5381-31	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5381	0781-5381-34	D	Discontinued by firm	2026-10-05
excluded package	package	0781-5381	0781-5381-92	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 2 · 72 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	0781-5381-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5381-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5381-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5381-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-5381-34	`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	0781-5381-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5381-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5381-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5381-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-5381-34	`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	0781-5381-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5381-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5381-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5381-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-5381-34	`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	0781-5381-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5381-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5381-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5381-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-5381-34	`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	0781-5381-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5381-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5381-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5381-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-5381-34	`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	0781-5381-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5381-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5381-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5381-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-5381-34	`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	0781-5381-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5381-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5381-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5381-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-5381-34	`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	0781-5381-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5381-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5381-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5381-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-5381-34	`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	0781-5381-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5381-92	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5381-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5381-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-5381-34	`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	0781-5381-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5381-92	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5381-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5381-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-5381-34	`ad56d346431e…`	`cc804d4bbf1e…`

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
A077575-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A077575-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A077575-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A077575-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077575-001	AB
A077575-002	AB
A077575-003	AB
A077575-004	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	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A077575-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077575-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077575-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077575-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077575-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077575-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077575-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077575-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077575-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077575-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077575-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077575-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077575-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077575-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077575-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077575-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077575-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077575-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077575-004	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
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-5381-92	EA - Each	0781-5381	d46c24a4-0661-4f34-b7e9-3a2f3f0eb086	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC]	6

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	f953ade5-c021-488e-80a6-8bdb70c4161b	1
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	f953ade5-c021-488e-80a6-8bdb70c4161b	1
617312	atorvastatin 10 MG Oral Tablet	SCD	f953ade5-c021-488e-80a6-8bdb70c4161b	1
617310	atorvastatin 20 MG Oral Tablet	SCD	f953ade5-c021-488e-80a6-8bdb70c4161b	1
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	f953ade5-c021-488e-80a6-8bdb70c4161b	1
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	f953ade5-c021-488e-80a6-8bdb70c4161b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-5381-92	00781538192	90 TABLET, FILM COATED in 1 BOTTLE (0781-5381-92)	2012-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Sandoz Inc	2023-01-30	HUMAN PRESCRIPTION DRUG LABEL	14
Atorvastatin Calcium	Cambridge Therapeutics Technologies, LLC	2016-10-21	HUMAN PRESCRIPTION DRUG LABEL	1