ATORVASTATIN CALCIUM

Product NDC: 68071-3267
Requested package NDC: 68071-3267-9
11-digit product format: 680713267
Labeler code: 68071
Product ID: 68071-3267_2d53fdee-0fc2-2c7f-e063-6294a90ab8f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA205519
Marketing category: ANDA
Marketing start: 2016-08-04
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 · 3 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	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3267	68071-3267-9	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3267	68071-3267-9	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3267	68071-3267-9	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205519-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205519-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205519-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205519-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2016-05-19	`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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205519-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205519-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205519-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205519-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205519-004	AB	1	`d06236e962d9…`

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
51f23212-a10d-4cfa-e054-00144ff88e88	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
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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3267-9	2025-02-04	C162847	48780-1	2cef2736-6184-d83d-e063-dadaa90ab31f	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: 1996
68071-3267-9	2025-01-30	C162847	48780-1	2cef2736-6184-d83d-e063-dadaa90ab31f	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: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3267-9	ATORVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3267	ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250206_51f23212-a10d-4cfa-e054-00144ff88e88.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	2026-05-07	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 ndc (package): 68071-3267-9 ndc (product): 68071-3267 ndc11 (package): 68071326709
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

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	51f23212-a10d-4cfa-e054-00144ff88e88	4
617311	atorvastatin 40 MG Oral Tablet	SCD	51f23212-a10d-4cfa-e054-00144ff88e88	4
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	51f23212-a10d-4cfa-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3267-9	68071326709	90 TABLET, FILM COATED in 1 BOTTLE (68071-3267-9)	2017-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc. \| NuCarePharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	4