Atorvastatin Calcium

Product NDC: 0378-3953
11-digit product format: 003783953
Labeler code: 0378
Product ID: 0378-3953_c94bf799-ec3d-4644-b1a2-3c7b3f612e19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atorvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA091226
Marketing category: ANDA
Marketing start: 2013-09-19
Substance: ATORVASTATIN CALCIUM TRIHYDRATE
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

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	80 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	48A5M73Z4Q
Rxcui	259255, 617310, 617311, 617312

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-3953-05	Atorvastatin Calcium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	27
0378-3953-07	Atorvastatin Calcium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	27
0378-3953-09	Atorvastatin Calcium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	27
0378-3953-77	Atorvastatin Calcium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3953-07	EA - Each	0378-3953	ca69f903-79ed-445b-a7f3-6980ebc55a15	1	2015-10-02
0378-3953-09	EA - Each	0378-3953	0e1c63ae-69e1-4d49-9824-84d973713cd1	1	2015-10-02
0378-3953-77	EA - Each	0378-3953	11de9f0a-fa5b-47f0-ab05-28d77e7b832b	1	2013-11-04

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 [MYLAN PHARMACEUTICALS INC.]	12
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	12
ATORVASTATIN CALCIUM TRIHYDRATE	ACTIVE INGREDIENT	48A5M73Z4Q	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
ATORVASTATIN	ACTIVE MOIETY	A0JWA85V8F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3953	ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	27	Current NDC, Legacy NDC, 4 package rows	20240719_d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d.zip

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
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617312	atorvastatin 10 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617310	atorvastatin 20 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617311	atorvastatin 40 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
259255	atorvastatin 80 MG Oral Tablet	SCD	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	27
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617312	atorvastatin 10 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617310	atorvastatin 20 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617311	atorvastatin 40 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
259255	atorvastatin 80 MG Oral Tablet	SCD	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	7c1083b9-7a20-475d-ba12-4f5d0b53e601	15
617312	atorvastatin calcium 10 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617310	atorvastatin calcium 20 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617311	atorvastatin calcium 40 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
259255	atorvastatin calcium 80 MG Oral Tablet	PSN	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617312	atorvastatin 10 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617310	atorvastatin 20 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617311	atorvastatin 40 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
259255	atorvastatin 80 MG Oral Tablet	SCD	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617312	atorvastatin (as atorvastatin calcium) 10 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617310	atorvastatin (as atorvastatin calcium) 20 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
617311	atorvastatin (as atorvastatin calcium) 40 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2
259255	atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet	SY	6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3953-05	00378395305	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-05)	2014-02-14	0000-00-00	No	No	Current
0378-3953-07	00378395307	500 in 1 BOTTLE, PLASTIC					Historical
0378-3953-09	00378395309	90 in 1 BOTTLE, PLASTIC					Historical
0378-3953-77	00378395377	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3953-77)	2013-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atorvastatin Calcium	Safecor Health, LLC	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	2
Atorvastatin Calcium	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	15
Atorvastatin Calcium	Mylan Pharmaceuticals Inc.	2024-04-12	HUMAN PRESCRIPTION DRUG LABEL	27

Atorvastatin Calcium

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#