FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
71335-2697
11-digit product format
713352697
Labeler code
71335
Product ID
71335-2697_91732291-fffd-4ec7-820a-917b898d2caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213853
Marketing category
ANDA
Marketing start
2020-08-26
Substance
ATORVASTATIN
Active strength
40 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
ATORVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
Rxcui617311

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
71335-2697-1Atorvastatin calcium30 in 1 BOTTLETABLET302
71335-2697-2Atorvastatin calcium100 in 1 BOTTLETABLET1002
71335-2697-3Atorvastatin calcium90 in 1 BOTTLETABLET902
71335-2697-4Atorvastatin calcium60 in 1 BOTTLETABLET602
71335-2697-5Atorvastatin calcium180 in 1 BOTTLETABLET1802
71335-2697-6Atorvastatin calcium10 in 1 BOTTLETABLET102
71335-2697-7Atorvastatin calcium7 in 1 BOTTLETABLET72
71335-2697-8Atorvastatin calcium20 in 1 BOTTLETABLET202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN20f820ba-9600-4b51-bf23-8c99e815674c2
617311atorvastatin 40 MG Oral TabletSCD20f820ba-9600-4b51-bf23-8c99e815674c2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY20f820ba-9600-4b51-bf23-8c99e815674c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2697-17133526970130 TABLET in 1 BOTTLE (71335-2697-1) 30 tablet2025-09-24NoNoHistorical
71335-2697-271335269702100 TABLET in 1 BOTTLE (71335-2697-2) 100 tablet2025-09-24NoNoHistorical
71335-2697-37133526970390 TABLET in 1 BOTTLE (71335-2697-3) 90 tablet2025-09-24NoNoHistorical
71335-2697-47133526970460 TABLET in 1 BOTTLE (71335-2697-4) 60 tablet2025-09-24NoNoHistorical
71335-2697-571335269705180 TABLET in 1 BOTTLE (71335-2697-5) 180 tablet2025-09-24NoNoHistorical
71335-2697-67133526970610 TABLET in 1 BOTTLE (71335-2697-6) 10 tablet2025-09-24NoNoHistorical
71335-2697-7713352697077 TABLET in 1 BOTTLE (71335-2697-7) 7 tablet2025-09-24NoNoHistorical
71335-2697-87133526970820 TABLET in 1 BOTTLE (71335-2697-8) 20 tablet2025-09-24NoNoHistorical