FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-2241
11-digit product format
713352241
Labeler code
71335
Product ID
71335-2241_e21371a6-df28-41fb-b855-aaa4c1950731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
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
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 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
71335-2241-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30104
71335-2241-2Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90104
71335-2241-3Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60104
71335-2241-4Atorvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120104
71335-2241-5Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED100104
71335-2241-6Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2241ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 6 package rows20250228_2035c49b-f319-4dce-bf1c-c2f64e786fb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN2035c49b-f319-4dce-bf1c-c2f64e786fb7104
617312atorvastatin 10 MG Oral TabletSCD2035c49b-f319-4dce-bf1c-c2f64e786fb7104
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2035c49b-f319-4dce-bf1c-c2f64e786fb7104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2241-17133522410130 TABLET, FILM COATED in 1 BOTTLE (71335-2241-1) 2023-11-07NoNoCurrent
71335-2241-27133522410290 TABLET, FILM COATED in 1 BOTTLE (71335-2241-2) 2023-10-10NoNoCurrent
71335-2241-37133522410360 TABLET, FILM COATED in 1 BOTTLE (71335-2241-3) 2025-01-31NoNoCurrent
71335-2241-471335224104120 TABLET, FILM COATED in 1 BOTTLE (71335-2241-4) 2024-01-23NoNoCurrent
71335-2241-571335224105100 TABLET, FILM COATED in 1 BOTTLE (71335-2241-5) 2025-01-31NoNoCurrent
71335-2241-671335224106180 TABLET, FILM COATED in 1 BOTTLE (71335-2241-6) 2025-01-31NoNoCurrent