FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
0904-6292
11-digit product format
009046292
Labeler code
0904
Product ID
0904-6292_cfa7738f-f1a2-41ef-975e-ffa8f94f1b44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090548
Marketing category
ANDA
Marketing start
2014-10-31
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVASTATIN CALCIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui259255, 617311

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6292-06ATORVASTATIN CALCIUM1 in 1 BLISTER PACKTABLET, FILM COATED110
0904-6292-06ATORVASTATIN CALCIUM50 in 1 CARTONTABLET, FILM COATED5010
0904-6292-61ATORVASTATIN CALCIUM100 in 1 CARTONTABLET, FILM COATED10010
0904-6292-61ATORVASTATIN CALCIUM1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6292-06EA - Each0904-62925bbfb605-c859-41fd-af73-397ddb33133b12020-06-05
0904-6292-61EA - Each0904-6292e6806836-518b-4f5f-abdd-91736fb8269e12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6292ATORVASTATIN CALCIUM TABLET, FILM COATED [MAJOR PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20240621_e74278b6-31fc-48d4-97b7-ba500e9e15fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN75ea68e0-12e2-4e27-876f-f24f6e33a0b719
259255atorvastatin calcium 80 MG Oral TabletPSN75ea68e0-12e2-4e27-876f-f24f6e33a0b719
617311atorvastatin 40 MG Oral TabletSCD75ea68e0-12e2-4e27-876f-f24f6e33a0b719
259255atorvastatin 80 MG Oral TabletSCD75ea68e0-12e2-4e27-876f-f24f6e33a0b719
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY75ea68e0-12e2-4e27-876f-f24f6e33a0b719
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY75ea68e0-12e2-4e27-876f-f24f6e33a0b719
617311atorvastatin calcium 40 MG Oral TabletPSNe74278b6-31fc-48d4-97b7-ba500e9e15fb10
259255atorvastatin calcium 80 MG Oral TabletPSNe74278b6-31fc-48d4-97b7-ba500e9e15fb10
617311atorvastatin 40 MG Oral TabletSCDe74278b6-31fc-48d4-97b7-ba500e9e15fb10
259255atorvastatin 80 MG Oral TabletSCDe74278b6-31fc-48d4-97b7-ba500e9e15fb10
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYe74278b6-31fc-48d4-97b7-ba500e9e15fb10
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYe74278b6-31fc-48d4-97b7-ba500e9e15fb10
617311atorvastatin calcium 40 MG Oral TabletPSN1272aada-9a5b-4397-bb65-9398927aa3256
617311atorvastatin 40 MG Oral TabletSCD1272aada-9a5b-4397-bb65-9398927aa3256
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1272aada-9a5b-4397-bb65-9398927aa3256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6292-060090462920650 BLISTER PACK in 1 CARTON (0904-6292-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2014-10-310000-00-00NoNoCurrent
0904-6292-6100904629261100 BLISTER PACK in 1 CARTON (0904-6292-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2014-10-310000-00-00NoNoCurrent