FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
63304-830
11-digit product format
633040830
Labeler code
63304
Product ID
63304-830_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
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
2027-12-31

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
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-830-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50019
63304-830-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-830-05EA - Each63304-830b2cf6c45-409a-40a6-9c20-40708594f4d112012-07-24
63304-830-90EA - Each63304-830e9ed56b3-af7e-443f-908d-b6f5d0f4715312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
POLYSORBATE 65INACTIVE INGREDIENT14BGY2Y3MJATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RATORVASTATIN CALCIUM TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
METHYLCELLULOSE (400 CPS)INACTIVE INGREDIENTO0GN6F9B2YATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYSORBATE 65INACTIVE INGREDIENT14BGY2Y3MJATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RATORVASTATIN CALCIUM TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
METHYLCELLULOSE (400 CPS)INACTIVE INGREDIENTO0GN6F9B2YATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 65INACTIVE INGREDIENT14BGY2Y3MJATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-830ATORVASTATIN CALCIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES INC.]19Current NDC, Legacy NDC, 2 package rows20240426_595ab888-6b55-4642-a32f-e8521821ed81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN595ab888-6b55-4642-a32f-e8521821ed8119
617310atorvastatin calcium 20 MG Oral TabletPSN595ab888-6b55-4642-a32f-e8521821ed8119
617311atorvastatin calcium 40 MG Oral TabletPSN595ab888-6b55-4642-a32f-e8521821ed8119
259255atorvastatin calcium 80 MG Oral TabletPSN595ab888-6b55-4642-a32f-e8521821ed8119
617312atorvastatin 10 MG Oral TabletSCD595ab888-6b55-4642-a32f-e8521821ed8119
617310atorvastatin 20 MG Oral TabletSCD595ab888-6b55-4642-a32f-e8521821ed8119
617311atorvastatin 40 MG Oral TabletSCD595ab888-6b55-4642-a32f-e8521821ed8119
259255atorvastatin 80 MG Oral TabletSCD595ab888-6b55-4642-a32f-e8521821ed8119
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY595ab888-6b55-4642-a32f-e8521821ed8119
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY595ab888-6b55-4642-a32f-e8521821ed8119
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY595ab888-6b55-4642-a32f-e8521821ed8119
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY595ab888-6b55-4642-a32f-e8521821ed8119
617312atorvastatin calcium 10 MG Oral TabletPSNafd5c7b3-4886-4250-9a12-b61451f65eb54
617310atorvastatin calcium 20 MG Oral TabletPSNafd5c7b3-4886-4250-9a12-b61451f65eb54
617311atorvastatin calcium 40 MG Oral TabletPSNafd5c7b3-4886-4250-9a12-b61451f65eb54
259255atorvastatin calcium 80 MG Oral TabletPSNafd5c7b3-4886-4250-9a12-b61451f65eb54
617312atorvastatin 10 MG Oral TabletSCDafd5c7b3-4886-4250-9a12-b61451f65eb54
617310atorvastatin 20 MG Oral TabletSCDafd5c7b3-4886-4250-9a12-b61451f65eb54
617311atorvastatin 40 MG Oral TabletSCDafd5c7b3-4886-4250-9a12-b61451f65eb54
259255atorvastatin 80 MG Oral TabletSCDafd5c7b3-4886-4250-9a12-b61451f65eb54
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYafd5c7b3-4886-4250-9a12-b61451f65eb54
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYafd5c7b3-4886-4250-9a12-b61451f65eb54
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYafd5c7b3-4886-4250-9a12-b61451f65eb54
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYafd5c7b3-4886-4250-9a12-b61451f65eb54
259255atorvastatin calcium 80 MG Oral TabletPSNb1a840cf-47aa-b931-e053-2a95a90a10473
259255atorvastatin calcium 80 MG Oral TabletPSNb378ec00-a711-4ca3-9d79-ae33282581793
259255atorvastatin 80 MG Oral TabletSCDb378ec00-a711-4ca3-9d79-ae33282581793
259255atorvastatin 80 MG Oral TabletSCDb1a840cf-47aa-b931-e053-2a95a90a10473
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYb378ec00-a711-4ca3-9d79-ae33282581793
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYb1a840cf-47aa-b931-e053-2a95a90a10473
617312atorvastatin calcium 10 MG Oral TabletPSN28e28cc3-349a-427a-b19c-77503ef43db41
617310atorvastatin calcium 20 MG Oral TabletPSN28e28cc3-349a-427a-b19c-77503ef43db41
617311atorvastatin calcium 40 MG Oral TabletPSN28e28cc3-349a-427a-b19c-77503ef43db41
259255atorvastatin calcium 80 MG Oral TabletPSNa16959a0-f840-4fe8-8af2-0e9942f6f90a1
259255atorvastatin calcium 80 MG Oral TabletPSN28e28cc3-349a-427a-b19c-77503ef43db41
617312atorvastatin 10 MG Oral TabletSCD28e28cc3-349a-427a-b19c-77503ef43db41
617310atorvastatin 20 MG Oral TabletSCD28e28cc3-349a-427a-b19c-77503ef43db41
617311atorvastatin 40 MG Oral TabletSCD28e28cc3-349a-427a-b19c-77503ef43db41
259255atorvastatin 80 MG Oral TabletSCD28e28cc3-349a-427a-b19c-77503ef43db41
259255atorvastatin 80 MG Oral TabletSCDa16959a0-f840-4fe8-8af2-0e9942f6f90a1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY28e28cc3-349a-427a-b19c-77503ef43db41
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY28e28cc3-349a-427a-b19c-77503ef43db41
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY28e28cc3-349a-427a-b19c-77503ef43db41
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY28e28cc3-349a-427a-b19c-77503ef43db41
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYa16959a0-f840-4fe8-8af2-0e9942f6f90a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-830-0563304083005500 TABLET, FILM COATED in 1 BOTTLE (63304-830-05) 2011-12-010000-00-00NoNoCurrent
63304-830-906330408309090 TABLET, FILM COATED in 1 BOTTLE (63304-830-90) 2011-12-010000-00-00NoNoCurrent