FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-9723
11-digit product format
713359723
Labeler code
71335
Product ID
71335-9723_6b6c1e31-f207-400f-9599-a2f96c5bb3c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214659
Marketing category
ANDA
Marketing start
2022-08-29
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
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
71335-9723-1Atorvastatin Calcium30 in 1 BOTTLETABLET30103
71335-9723-2Atorvastatin Calcium100 in 1 BOTTLETABLET100103
71335-9723-3Atorvastatin Calcium90 in 1 BOTTLETABLET90103
71335-9723-4Atorvastatin Calcium60 in 1 BOTTLETABLET60103
71335-9723-5Atorvastatin Calcium180 in 1 BOTTLETABLET180103
71335-9723-6Atorvastatin Calcium10 in 1 BOTTLETABLET10103
71335-9723-7Atorvastatin Calcium7 in 1 BOTTLETABLET7103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9723ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]103Current NDC, 7 package rows20241115_a20bac35-a3d7-4e97-95c2-2502107d61c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSNa20bac35-a3d7-4e97-95c2-2502107d61c2103
617311atorvastatin 40 MG Oral TabletSCDa20bac35-a3d7-4e97-95c2-2502107d61c2103
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYa20bac35-a3d7-4e97-95c2-2502107d61c2103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9723-17133597230130 TABLET in 1 BOTTLE (71335-9723-1) 30 tablet2023-07-06NoNoHistorical
71335-9723-271335972302100 TABLET in 1 BOTTLE (71335-9723-2) 100 tablet2024-04-22NoNoHistorical
71335-9723-37133597230390 TABLET in 1 BOTTLE (71335-9723-3) 90 tablet2023-06-07NoNoHistorical
71335-9723-47133597230460 TABLET in 1 BOTTLE (71335-9723-4) 60 tablet2024-07-16NoNoHistorical
71335-9723-571335972305180 TABLET in 1 BOTTLE (71335-9723-5) 180 tablet2024-04-22NoNoHistorical
71335-9723-67133597230610 TABLET in 1 BOTTLE (71335-9723-6) 10 tablet2024-04-22NoNoHistorical
71335-9723-7713359723077 TABLET in 1 BOTTLE (71335-9723-7) 7 tablet2024-07-16NoNoHistorical