ATORVASTATIN CALCIUM

Product NDC: 71335-1126
Requested package NDC: 71335-1126-4
11-digit product format: 713351126
Labeler code: 71335
Product ID: 71335-1126_304d9a7c-00e9-48f8-ad99-21fc4575f188
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207687
Marketing category: ANDA
Marketing start: 2018-08-06
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: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1126	71335-1126-4	I	Inactivated by FDA		excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1126	71335-1126-4	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A207687-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30
A207687-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30
A207687-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30
A207687-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207687-001	AB
A207687-002	AB
A207687-003	AB
A207687-004	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	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2018-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2018-03-30	`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	A207687-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207687-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207687-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207687-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207687-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207687-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207687-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207687-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207687-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207687-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207687-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207687-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207687-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207687-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207687-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207687-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207687-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207687-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207687-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207687-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207687-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207687-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ATORVASTATIN CALCIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48A5M73Z4Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
617311	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1fb2d51e-360c-40a3-8072-f22893890a51	Available on FDA.report

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
71335-1126-1	2024-05-20	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
71335-1126-2	2024-05-20	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
71335-1126-3	2024-05-20	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
71335-1126-4	2024-05-20	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
71335-1126-5	2024-05-20	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
71335-1126-6	2024-05-20	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
71335-1126-1	2024-01-30	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
71335-1126-2	2024-01-30	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
71335-1126-3	2024-01-30	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
71335-1126-4	2024-01-30	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
71335-1126-5	2024-01-30	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
71335-1126-6	2024-01-30	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1126-1	ATORVASTATIN CALCIUM	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
71335-1126-2	ATORVASTATIN CALCIUM	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
71335-1126-3	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90	7
71335-1126-4	ATORVASTATIN CALCIUM	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
71335-1126-5	ATORVASTATIN CALCIUM	180 in 1 BOTTLE	TABLET, FILM COATED	180	7
71335-1126-6	ATORVASTATIN CALCIUM	10 in 1 BOTTLE	TABLET, FILM COATED	10	7
71335-1126-7	ATORVASTATIN CALCIUM	7 in 1 BOTTLE	TABLET, FILM COATED	7	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1126	ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]	7	Current NDC, Legacy NDC, 7 package rows	20241116_1fb2d51e-360c-40a3-8072-f22893890a51.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	c095d497-0634-6413-e053-2a95a90aa67f	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	df6233cf-5b4e-5fbe-e053-2a95a90a0a80	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Accord Healthcare Inc.	4e06b20d-cc5d-46eb-991b-5972248de3af	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	1fb2d51e-360c-40a3-8072-f22893890a51	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687 ndc (package): 71335-1126-4 ndc (product): 71335-1126 ndc11 (package): 71335112604
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	cbeb2aa0-24a2-430f-b456-34a4e63e1817	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	ace2c37e-b525-4fe7-8316-9bd3fa4a092c	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	9e014adf-251e-126e-e053-2995a90a05bf	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	a0835fa8-bd55-33bd-e053-2a95a90a96b1	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	a0732bc4-702d-f566-e053-2a95a90a1d69	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	a1b22973-cb9a-473e-a240-112b3e84e97c	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	e931003a-3a8d-48b9-b13f-e620017303f6	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	1923c91e-c6dd-4446-aabd-70a0c6aa1a82	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207687 application number: ANDA207687

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
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	1fb2d51e-360c-40a3-8072-f22893890a51	7
617311	atorvastatin 40 MG Oral Tablet	SCD	1fb2d51e-360c-40a3-8072-f22893890a51	7
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	1fb2d51e-360c-40a3-8072-f22893890a51	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1126-4	71335112604	60 TABLET, FILM COATED in 1 BOTTLE (71335-1126-4)	2024-10-31	0000-00-00	No	No	Current