Atorvastatin Calcium

Product NDC
55154-6635
11-digit product format
551546635
Labeler code
55154
Product ID
55154-6635_8922e6cc-453f-4271-91da-e93803b0ab43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2013-07-29
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
2027-12-31
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 PROPYLENE GLYCOL SOLVATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617310, 617311, 617312

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
55154-6635-0Atorvastatin Calcium10 in 1 BAGTABLET, FILM COATED1018
55154-6635-0Atorvastatin Calcium1 in 1 BLISTER PACKTABLET, FILM COATED118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-6635-0EA - Each55154-6635c92a25b5-8500-40db-9048-e014c1ea89fd12019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6635ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]16Current NDC, Legacy NDC, 2 package rows20250130_ed0d5c17-0481-4d6b-8051-8d6e47f49ce5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617310atorvastatin calcium 20 MG Oral TabletPSNed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617311atorvastatin calcium 40 MG Oral TabletPSNed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617312atorvastatin 10 MG Oral TabletSCDed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617310atorvastatin 20 MG Oral TabletSCDed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617311atorvastatin 40 MG Oral TabletSCDed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYed0d5c17-0481-4d6b-8051-8d6e47f49ce518
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYed0d5c17-0481-4d6b-8051-8d6e47f49ce518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-6635-05515466350010 BLISTER PACK in 1 BAG (55154-6635-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-07-290000-00-00NoNoCurrent