ATORVASTATIN CALCIUM

Product NDC: 43353-120
11-digit product format: 433530120
Labeler code: 43353
Product ID: 43353-120_67dce28b-a634-42eb-b565-93d513ab9b10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA020702
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-01-28
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: 2020-12-31
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	43353-120		I	Inactivated by FDA	2026-08-17
excluded package	package	43353-120	43353-120-45	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-120	43353-120-60	I	Inactivated by FDA	2026-08-17

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	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	43353-120-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-120-60	`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	43353-120-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-120-60	`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	43353-120-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-120-60	`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	43353-120-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-120-60	`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	43353-120-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-120-60	`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	43353-120-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-120-60	`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	43353-120-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-120-60	`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	43353-120-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-120-60	`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	43353-120-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-120-60	`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	43353-120-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-120-60	`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	43353-120-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-120-60	`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	43353-120-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-120-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-120-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-120-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-120-45	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-120-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-120-45	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-120-60	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N020702-001	LIPITOR	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17
N020702-002	LIPITOR	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17
N020702-003	LIPITOR	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17
N020702-004	LIPITOR	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020702-001	AB
N020702-002	AB
N020702-003	AB
N020702-004	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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-001	LIPITOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-002	LIPITOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-003	LIPITOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD	1996-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-004	LIPITOR	EQ 80MG BASE	TABLET / ORAL	AB	RLD, RS	2000-04-07	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020702-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020702-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020702-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020702-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020702-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020702-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020702-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020702-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020702-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020702-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020702-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020702-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020702-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020702-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020702-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020702-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020702-004	AB	1	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020702-001	M-204	2020-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020702-002	M-204	2020-06-23	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020702-001	M-204	2020-06-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020702-002	M-204	2020-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020702-001	M-204	2020-06-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020702-002	M-204	2020-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020702-001	M-204	2020-06-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020702-002	M-204	2020-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020702-001	M-204	2020-06-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020702-002	M-204	2020-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020702-001	M-204	2020-06-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020702-002	M-204	2020-06-23	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-120-45	2023-01-30	C162847	48780-1	f386c649-d762-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1996
43353-120-60	2023-01-30	C162847	48780-1	f386c649-d762-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-120-45	ATORVASTATIN CALCIUM	45 in 1 BOTTLE	TABLET, FILM COATED	45		4
43353-120-60	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-120-60	EA - Each	43353-120	1f9d1cb1-db76-4716-a7d5-fb9841e1259d	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-120	ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Legacy NDC, 2 package rows	20191219_b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c.zip

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
Lipitor	ATORVASTATIN CALCIUM	Viatris Specialty LLC	a60cc18b-0631-4cf0-b021-9f52224ece65	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020702 application number: NDA020702

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	b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c	4
617312	atorvastatin 10 MG Oral Tablet	SCD	b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c	4
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-120-45	43353012045	45 TABLET, FILM COATED in 1 BOTTLE (43353-120-45)	2015-11-04	0000-00-00	No	No	Current
43353-120-60	43353012060	90 TABLET, FILM COATED in 1 BOTTLE (43353-120-60)	2016-01-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC \| Aphena Pharma Solutions - Tennesssee, LLC	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	4