ATORVASTATIN CALCIUM

Product NDC: 0904-6293
11-digit product format: 009046293
Labeler code: 0904
Product ID: 0904-6293_cfa7738f-f1a2-41ef-975e-ffa8f94f1b44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATORVASTATIN CALCIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA090548
Marketing category: ANDA
Marketing start: 2014-10-31
Substance: ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength: 80 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

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
A090548-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090548-001	AB
A090548-002	AB
A090548-003	AB
A090548-004	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	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`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	A090548-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090548-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090548-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: ATORVASTATIN CALCIUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YRZ789OWMI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259255	Internal RxNorm lookup
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
e74278b6-31fc-48d4-97b7-ba500e9e15fb	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
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6293-04	ATORVASTATIN CALCIUM	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		10
0904-6293-04	ATORVASTATIN CALCIUM	30 in 1 CARTON	TABLET, FILM COATED	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6293-04	EA - Each	0904-6293	b4a3fd45-1636-4916-b793-9572ff723e12	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE	ACTIVE INGREDIENT	YRZ789OWMI	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CALCIUM ACETATE	INACTIVE INGREDIENT	Y882YXF34X	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6293	ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20240621_e74278b6-31fc-48d4-97b7-ba500e9e15fb.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	e74278b6-31fc-48d4-97b7-ba500e9e15fb	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 0904-6293
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	52d8508b-aa98-cd89-5991-e2b5f982b6c6	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	303989c9-823e-4bcb-a7b3-7024fd0d3a38	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	e91c673d-c26c-4ff1-90d2-2b9d47a8d771	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	d57720ab-9f83-4da9-a57f-0d55e00a605c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Unit Dose Solutions, Inc.	53c06fa9-ec26-5fa6-e063-6294a90a337f	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	ed57fc60-ecb2-419e-b09f-3c518dcf3d04	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	1272aada-9a5b-4397-bb65-9398927aa325	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	ed0d5c17-0481-4d6b-8051-8d6e47f49ce5	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	AvPAK	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	4a2bad30-e7cf-c48a-e063-6294a90a5f47	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	09c6c750-ae05-459f-83e8-4a9e4fd85212	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f32c8a4f-dee9-86a0-e053-2995a90a3388	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f76b9e48-3ef7-e15a-e053-6394a90aed58	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	0e10adb3-8d3a-412f-ae56-d9b9bed4641f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	0c5823ce-ed5c-356c-e063-6394a90aa15d	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma, Inc.	f7cc5704-2131-4bcb-9ff0-33a79a8167bd	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma, Inc.	d8a72abf-1d43-47e1-88e8-c3c5cc4ba163	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	7353f9ef-6f79-4522-886a-7a8ae4eb867e	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YRZ789OWMI	ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE	1040350-07-9	ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	19
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	19
617311	atorvastatin 40 MG Oral Tablet	SCD	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	19
259255	atorvastatin 80 MG Oral Tablet	SCD	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	19
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	19
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	19
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	e74278b6-31fc-48d4-97b7-ba500e9e15fb	10
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	e74278b6-31fc-48d4-97b7-ba500e9e15fb	10
617311	atorvastatin 40 MG Oral Tablet	SCD	e74278b6-31fc-48d4-97b7-ba500e9e15fb	10
259255	atorvastatin 80 MG Oral Tablet	SCD	e74278b6-31fc-48d4-97b7-ba500e9e15fb	10
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	e74278b6-31fc-48d4-97b7-ba500e9e15fb	10
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	e74278b6-31fc-48d4-97b7-ba500e9e15fb	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6293-04	00904629304	30 BLISTER PACK in 1 CARTON (0904-6293-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK	30 blister pack	2014-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATORVASTATIN CALCIUM	Major Pharmaceuticals	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	11
ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	20