ATORVASTATIN CALCIUM

Product NDC: 10135-651
11-digit product format: 101350651
Labeler code: 10135
Product ID: 10135-651_024aa21f-3c16-47ba-a652-f2c9db7f5941
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA205519
Marketing category: ANDA
Marketing start: 2018-04-01
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10135-651		I	Inactivated by FDA		2026-10-05
excluded package	package	10135-651	10135-651-10	I	Inactivated by FDA		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 · 42 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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`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	10135-651-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-651-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-651-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-651-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-651-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10135-651-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10135-651-10	`9bebd1f3094a…`	`5416666fcb17…`

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
A205519-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19
A205519-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19
A205519-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19
A205519-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205519-001	AB
A205519-002	AB
A205519-003	AB
A205519-004	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	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`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	A205519-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205519-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205519-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205519-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205519-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205519-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205519-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205519-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205519-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205519-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205519-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205519-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205519-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205519-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205519-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205519-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205519-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205519-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-651-10	2020-01-31	C162847	48780-1	9d75b9cf-e072-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium tablets. ATORVASTATIN calcium tablets for oral use Initial U.S. Approval: 19 9 6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-651-10	ATORVASTATIN CALCIUM	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-651-10	EA - Each	10135-651	cdaef9a7-c3ac-45e0-bef8-dc90e78cf411	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-651	ATORVASTATIN CALCIUM TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	2	Legacy NDC, 1 package rows	20180913_64abfa40-e0ab-46ae-8c7c-7c199b89b7c1.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	ScieGen Pharmaceuticals, Inc.	f2d8b5e9-6ff2-4efa-ab01-e13df29f7371	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Radha Pharmaceuticals, Inc.	10e766cc-c3fd-4584-a0d7-652c516e828c	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	d1b9e56b-1632-4450-b1ca-d8bcbba3fd7c	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	e873d38c-4bda-4101-be98-85b1601d09f7	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	1914264b-4c95-4066-91ca-b5c91d8b741e	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	5b9a5a36-7814-4d19-b146-01e819676ae2	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Coupler LLC	47cd0227-90a5-cdf6-e063-6294a90af661	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	44a39b5a-77b6-42e8-9319-df21d3678e02	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	635addf1-2024-4675-8d3c-380dc4548fbd	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	66df5c0b-be89-4fc7-8f8d-c7689952c662	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	271409d0-5500-4ed0-8730-5a93226a2191	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	51f23212-a10d-4cfa-e054-00144ff88e88	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	3dbeae00-89ab-48a6-9e57-8048facb2294	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	a34d3c72-ce91-47c7-86a1-f32caaed2c47	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	ed8e76a5-6b40-47fe-9018-25bfe690a4dd	2018-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cipla USA Inc.,	18fe5990-399d-416c-852f-e14974317b8b	2018-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	b16b3805-7e60-447c-b3df-7a9392b63c99	2018-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205519 application number: ANDA205519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617312	atorvastatin 10 MG Oral Tablet	SCD	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617310	atorvastatin 20 MG Oral Tablet	SCD	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617311	atorvastatin 40 MG Oral Tablet	SCD	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
259255	atorvastatin 80 MG Oral Tablet	SCD	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	64abfa40-e0ab-46ae-8c7c-7c199b89b7c1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-651-10	10135065110	1000 in 1 BOTTLE	Historical