ATORVASTATIN CALCIUM

Product NDC
33261-959
11-digit product format
332610959
Labeler code
33261
Product ID
33261-959_9c180770-0e8d-4dde-b049-8b3a615cf105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-959-30ATORVASTATIN CALCIUM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
33261-959-60ATORVASTATIN CALCIUM60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
33261-959-90ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-959-30EA - Each33261-959e49074d3-540e-468a-aed9-445d4d769d9f12015-10-02
33261-959-60EA - Each33261-9595879f574-aaa0-4145-9d60-b6a2578c2b2312015-10-02
33261-959-90EA - Each33261-959669e646f-a159-4bb7-8254-63d329d97a2c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-959ATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]4Legacy NDC, 3 package rows20140327_5eed38e6-acff-4a1d-bb92-ae0420006962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5eed38e6-acff-4a1d-bb92-ae04200069624
617312atorvastatin 10 MG Oral TabletSCD5eed38e6-acff-4a1d-bb92-ae04200069624
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5eed38e6-acff-4a1d-bb92-ae04200069624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-959-303326109593030 in 1 BOTTLE, PLASTICHistorical
33261-959-603326109596060 in 1 BOTTLE, PLASTICHistorical
33261-959-903326109599090 in 1 BOTTLE, PLASTICHistorical