Atorvastatin Calcium

Product NDC: 53002-1440
11-digit product format: 530021440
Labeler code: 53002
Product ID: 53002-1440_f7993792-af33-4431-bb8a-6ec679e5e805
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA091624
Marketing category: ANDA
Marketing start: 2013-04-05
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
Active strength: 40 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-1440		I	Inactivated by FDA	2026-08-10
excluded package	package	53002-1440	53002-1440-0	I	Inactivated by FDA	2026-08-10
excluded package	package	53002-1440	53002-1440-3	I	Inactivated by FDA	2026-08-10
excluded package	package	53002-1440	53002-1440-9	I	Inactivated by FDA	2026-08-10

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 · 48 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1440-0	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1440-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1440-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1440-0	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1440-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1440-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1440-0	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1440-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1440-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1440-0	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1440-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1440-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1440-0	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1440-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1440-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1440-0	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1440-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1440-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1440-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1440-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1440-0	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1440-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1440-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1440-0	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1440-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1440-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1440-0	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
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	53002-1440-0	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1440-9	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1440-3	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	53002-1440-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1440-9	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1440-0	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	53002-1440-3	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	53002-1440-0	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	53002-1440-9	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 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
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091624-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2013-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091624-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2013-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091624-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2013-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091624-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2013-04-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091624-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091624-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091624-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091624-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091624-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091624-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091624-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091624-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091624-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091624-004	AB	1	`5bbf6a4d5a75…`
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…`

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, Related label table
NDC	Effective	Related label
53002-1440-0	2025-01-30	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
53002-1440-3	2025-01-30	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
53002-1440-9	2025-01-30	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
53002-1440-0	2023-06-07	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
53002-1440-3	2023-06-07	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
53002-1440-9	2023-06-07	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
53002-1440-0	2023-01-30	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
53002-1440-3	2023-01-30	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
53002-1440-9	2023-01-30	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
53002-1440-0	2020-12-16	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
53002-1440-3	2020-12-16	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
53002-1440-9	2020-12-16	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
53002-1440-0	2020-01-31	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
53002-1440-3	2020-01-31	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
53002-1440-9	2020-01-31	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
53002-1440-0	Atorvastatin Calcium	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
53002-1440-3	Atorvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
53002-1440-9	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1440	ATORVASTATIN CALCIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	8	Legacy NDC, 3 package rows	20230609_e1d39d2f-7c65-4b68-acfa-0d345714ce6e.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	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617312	atorvastatin 10 MG Oral Tablet	SCD	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617310	atorvastatin 20 MG Oral Tablet	SCD	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617311	atorvastatin 40 MG Oral Tablet	SCD	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	e1d39d2f-7c65-4b68-acfa-0d345714ce6e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1440-0	53002144000	100 TABLET, FILM COATED in 1 BOTTLE (53002-1440-0)	2017-09-01	0000-00-00	No	No	Current
53002-1440-3	53002144003	30 TABLET, FILM COATED in 1 BOTTLE (53002-1440-3)	2017-09-01	0000-00-00	No	No	Current
53002-1440-9	53002144009	90 TABLET, FILM COATED in 1 BOTTLE (53002-1440-9)	2017-09-01	0000-00-00	No	No	Current