ATORVASTATIN CALCIUM

Product NDC
72162-1554
11-digit product format
721621554
Labeler code
72162
Product ID
72162-1554_03a2891e-3e1d-46d7-ad6a-05eaffac2079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205519
Marketing category
ANDA
Marketing start
2016-05-19
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

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
72162-1554-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1554-9EA - Each72162-155423060ae9-01f3-43bb-9666-2de384721b1112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1554ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240919_e873d38c-4bda-4101-be98-85b1601d09f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNe873d38c-4bda-4101-be98-85b1601d09f7102
617312atorvastatin 10 MG Oral TabletSCDe873d38c-4bda-4101-be98-85b1601d09f7102
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYe873d38c-4bda-4101-be98-85b1601d09f7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1554-97216215540990 TABLET, FILM COATED in 1 BOTTLE (72162-1554-9) 2016-05-19NoNoHistorical