FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
51079-211
11-digit product format
510790211
Labeler code
51079
Product ID
51079-211_3a398bf9-4f72-46b9-e063-6394a90af2d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA091226
Marketing category
ANDA
Marketing start
2014-01-23
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
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 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
51079-211-01Atorvastatin Calcium1 in 1 BLISTER PACKTABLET, FILM COATED115
51079-211-03Atorvastatin Calcium30 in 1 CARTONTABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-211-01EA - Each51079-211d09c2de3-d4ac-45ea-ae62-4614dd83fe9612014-04-03
51079-211-03EA - Each51079-211ae1a262e-7aef-4465-8c8d-4f0f92f3a2d112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
ARGININEINACTIVE INGREDIENT94ZLA3W45FATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]2
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
51079-211ATORVASTATIN CALCIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]14Current NDC, Legacy NDC, 2 package rows20250331_7c1083b9-7a20-475d-ba12-4f5d0b53e601.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
259255atorvastatin calcium 80 MG Oral TabletPSNaee307d6-b3fa-424f-8656-1f30ff413e9513
259255atorvastatin 80 MG Oral TabletSCDaee307d6-b3fa-424f-8656-1f30ff413e9513
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYaee307d6-b3fa-424f-8656-1f30ff413e9513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-211-01510790211011 in 1 BLISTER PACKHistorical
51079-211-035107902110330 BLISTER PACK in 1 CARTON (51079-211-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-211-01) 30 blister pack2014-01-230000-00-00NoNoCurrent