Atorvastatin Calcium

Product NDC: 63304-829
11-digit product format: 633040829
Labeler code: 63304
Product ID: 63304-829_24508d3d-eec0-4c5c-bfaa-d6e01a03fe80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atorvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries Inc.
Application: ANDA076477
Marketing category: ANDA
Marketing start: 2011-12-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A076477-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2011-11-30
A076477-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2011-11-30
A076477-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2011-11-30
A076477-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2011-11-30

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 · 168 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
2026-08-18 06:07:40	2026-07	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL		2011-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2011-11-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076477-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076477-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076477-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076477-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076477-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076477-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076477-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076477-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076477-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076477-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076477-004	AB	1	`1e350fbaab3a…`

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 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259255	Internal RxNorm lookup
617310	Internal RxNorm lookup
617311	Internal RxNorm lookup
617312	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
595ab888-6b55-4642-a32f-e8521821ed81	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63304-829-05	Atorvastatin Calcium	500 in 1 BOTTLE	TABLET, FILM COATED	500		19
63304-829-90	Atorvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-829-05	EA - Each	63304-829	5e32cb92-4da7-48cb-961c-66033dadd931	1	2012-07-24
63304-829-90	EA - Each	63304-829	8b32f6b4-614e-4e69-a2fa-78df073cec84	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
POLYSORBATE 65	INACTIVE INGREDIENT	14BGY2Y3MJ	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]	7
ATORVASTATIN CALCIUM	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
METHYLCELLULOSE (400 CPS)	INACTIVE INGREDIENT	O0GN6F9B2Y	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
POLYSORBATE 65	INACTIVE INGREDIENT	14BGY2Y3MJ	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
ATORVASTATIN CALCIUM	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
ATORVASTATIN CALCIUM	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
METHYLCELLULOSE (400 CPS)	INACTIVE INGREDIENT	O0GN6F9B2Y	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 65	INACTIVE INGREDIENT	14BGY2Y3MJ	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-829	ATORVASTATIN CALCIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES INC.]	19	Current NDC, Legacy NDC, 2 package rows	20240426_595ab888-6b55-4642-a32f-e8521821ed81.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Sun Pharmaceutical Industries Inc.	595ab888-6b55-4642-a32f-e8521821ed81	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477 ndc (product): 63304-829
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	49dcc58a-9f23-045d-e063-6394a90abda6	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	DIRECT RX	c3b70f79-45a3-0869-e053-2a95a90a3cdb	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f7af3b3a-b73e-41ee-80e3-2be036672bb7	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b1a840cf-47aa-b931-e053-2a95a90a1047	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	d77e155c-403d-449e-bafd-11c9bd4974dd	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076477 application number: ANDA076477

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	2e583569-499d-4f20-87ca-84e7d9868d22	104
617311	atorvastatin 40 MG Oral Tablet	SCD	2e583569-499d-4f20-87ca-84e7d9868d22	104
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	2e583569-499d-4f20-87ca-84e7d9868d22	104
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	595ab888-6b55-4642-a32f-e8521821ed81	19
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	595ab888-6b55-4642-a32f-e8521821ed81	19
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	595ab888-6b55-4642-a32f-e8521821ed81	19
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	595ab888-6b55-4642-a32f-e8521821ed81	19
617312	atorvastatin 10 MG Oral Tablet	SCD	595ab888-6b55-4642-a32f-e8521821ed81	19
617310	atorvastatin 20 MG Oral Tablet	SCD	595ab888-6b55-4642-a32f-e8521821ed81	19
617311	atorvastatin 40 MG Oral Tablet	SCD	595ab888-6b55-4642-a32f-e8521821ed81	19
259255	atorvastatin 80 MG Oral Tablet	SCD	595ab888-6b55-4642-a32f-e8521821ed81	19
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	595ab888-6b55-4642-a32f-e8521821ed81	19
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	595ab888-6b55-4642-a32f-e8521821ed81	19
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	595ab888-6b55-4642-a32f-e8521821ed81	19
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	595ab888-6b55-4642-a32f-e8521821ed81	19
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617312	atorvastatin 10 MG Oral Tablet	SCD	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617310	atorvastatin 20 MG Oral Tablet	SCD	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617311	atorvastatin 40 MG Oral Tablet	SCD	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
259255	atorvastatin 80 MG Oral Tablet	SCD	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	afd5c7b3-4886-4250-9a12-b61451f65eb5	4
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	d77e155c-403d-449e-bafd-11c9bd4974dd	3
617311	atorvastatin 40 MG Oral Tablet	SCD	d77e155c-403d-449e-bafd-11c9bd4974dd	3
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	d77e155c-403d-449e-bafd-11c9bd4974dd	3
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	28e28cc3-349a-427a-b19c-77503ef43db4	1
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	28e28cc3-349a-427a-b19c-77503ef43db4	1
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	e0dfb540-67c3-3303-e053-2995a90a32e7	1
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	ed0f652a-41a4-b64e-e053-2995a90a916a	1
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	28e28cc3-349a-427a-b19c-77503ef43db4	1
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	28e28cc3-349a-427a-b19c-77503ef43db4	1
617312	atorvastatin 10 MG Oral Tablet	SCD	28e28cc3-349a-427a-b19c-77503ef43db4	1
617310	atorvastatin 20 MG Oral Tablet	SCD	28e28cc3-349a-427a-b19c-77503ef43db4	1
617311	atorvastatin 40 MG Oral Tablet	SCD	28e28cc3-349a-427a-b19c-77503ef43db4	1
617311	atorvastatin 40 MG Oral Tablet	SCD	e0dfb540-67c3-3303-e053-2995a90a32e7	1
617311	atorvastatin 40 MG Oral Tablet	SCD	ed0f652a-41a4-b64e-e053-2995a90a916a	1
259255	atorvastatin 80 MG Oral Tablet	SCD	28e28cc3-349a-427a-b19c-77503ef43db4	1
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	28e28cc3-349a-427a-b19c-77503ef43db4	1
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	28e28cc3-349a-427a-b19c-77503ef43db4	1
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	28e28cc3-349a-427a-b19c-77503ef43db4	1
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	e0dfb540-67c3-3303-e053-2995a90a32e7	1
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	ed0f652a-41a4-b64e-e053-2995a90a916a	1
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	28e28cc3-349a-427a-b19c-77503ef43db4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-829-05	63304082905	500 TABLET, FILM COATED in 1 BOTTLE (63304-829-05)	2011-12-01	0000-00-00	No	No	Current
63304-829-90	63304082990	90 TABLET, FILM COATED in 1 BOTTLE (63304-829-90)	2011-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Bryant Ranch Prepack	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	105
Atorvastatin Calcium	Sun Pharmaceutical Industries Inc. \| Sun Pharmaceutical Industries Limited	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	20
Atorvastatin Calcium	Preferred Pharmaceutical Inc.	2024-01-16	HUMAN PRESCRIPTION DRUG LABEL	2
Atorvastatin Calcium	ST. MARY'S MEDICAL PARK PHARMACY	2022-12-08	HUMAN PRESCRIPTION DRUG LABEL	1
Atorvastatin Calcium	NuCare Pharmaceuticals,Inc.	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	1
Atorvastatin Calcium	NuCare Pharmaceuticals,Inc.	2022-06-07	HUMAN PRESCRIPTION DRUG LABEL	1
Atorvastatin Calcium	Bryant Ranch Prepack	2022-02-28	HUMAN PRESCRIPTION DRUG LABEL	4
Atorvastatin Calcium	Bryant Ranch Prepack	2022-01-28	HUMAN PRESCRIPTION DRUG LABEL	2
Atorvastatin Calcium	REMEDYREPACK INC.	2021-09-20	HUMAN PRESCRIPTION DRUG LABEL	4
Atorvastatin Calcium	Proficient Rx LP	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Atorvastatin Calcium	NuCare Pharmaceuticals,Inc.	2018-06-28	HUMAN PRESCRIPTION DRUG LABEL	1
Atorvastatin Calcium - Northwind Pharmaceuticals	Northwind Pharmaceuticals	2014-04-03	HUMAN PRESCRIPTION DRUG LABEL	1
Atorvastatin Calcium	Physicians Total Care, Inc.	2013-07-11	HUMAN PRESCRIPTION DRUG LABEL	4
Atorvastatin Calcium	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-20	HUMAN PRESCRIPTION DRUG LABEL	1