FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
0378-3951
11-digit product format
003783951
Labeler code
0378
Product ID
0378-3951_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
20 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
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255, 617310, 617311, 617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3951-05Atorvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50027
0378-3951-07Atorvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50027
0378-3951-09Atorvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9027
0378-3951-77Atorvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3951-05EA - Each0378-3951b379f1c9-c5e1-4a1d-8586-564f075b63b712013-11-04
0378-3951-07EA - Each0378-3951b4dd6631-0e81-4a3e-b4fe-f4566774356612015-10-02
0378-3951-09EA - Each0378-3951ffc6f448-5ca4-4034-9ceb-7a614a31ab2c12015-10-02
0378-3951-77EA - Each0378-3951115204d4-9d92-4e11-8506-4591d4d6bbb512013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
ARGININEINACTIVE INGREDIENT94ZLA3W45FATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]12
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3951ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]27Current NDC, Legacy NDC, 4 package rows20240719_d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617310atorvastatin calcium 20 MG Oral TabletPSNd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617311atorvastatin calcium 40 MG Oral TabletPSNd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
259255atorvastatin calcium 80 MG Oral TabletPSNd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617312atorvastatin 10 MG Oral TabletSCDd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617310atorvastatin 20 MG Oral TabletSCDd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617311atorvastatin 40 MG Oral TabletSCDd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
259255atorvastatin 80 MG Oral TabletSCDd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYd0a0feb6-84f0-4693-a11f-eb4f7ae0a87d27
617312atorvastatin calcium 10 MG Oral TabletPSN7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617310atorvastatin calcium 20 MG Oral TabletPSN7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617311atorvastatin calcium 40 MG Oral TabletPSN7c1083b9-7a20-475d-ba12-4f5d0b53e60115
259255atorvastatin calcium 80 MG Oral TabletPSN7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617312atorvastatin 10 MG Oral TabletSCD7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617310atorvastatin 20 MG Oral TabletSCD7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617311atorvastatin 40 MG Oral TabletSCD7c1083b9-7a20-475d-ba12-4f5d0b53e60115
259255atorvastatin 80 MG Oral TabletSCD7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7c1083b9-7a20-475d-ba12-4f5d0b53e60115
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY7c1083b9-7a20-475d-ba12-4f5d0b53e60115
617312atorvastatin calcium 10 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617310atorvastatin calcium 20 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617311atorvastatin calcium 40 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
259255atorvastatin calcium 80 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617312atorvastatin 10 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617310atorvastatin 20 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617311atorvastatin 40 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
259255atorvastatin 80 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3951-0500378395105500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3951-05) 2013-10-220000-00-00NoNoCurrent
0378-3951-0700378395107500 in 1 BOTTLE, PLASTICHistorical
0378-3951-090037839510990 in 1 BOTTLE, PLASTICHistorical
0378-3951-770037839517790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3951-77) 2013-09-190000-00-00NoNoCurrent