FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-1710
11-digit product format
713351710
Labeler code
71335
Product ID
71335-1710_207707b9-50d8-4ad6-b9a2-9ea43d9f31bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
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
71335-1710-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30107
71335-1710-2Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90107
71335-1710-3Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60107
71335-1710-4Atorvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120107
71335-1710-5Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED100107
71335-1710-6Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1710ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 6 package rows20240823_f7af3b3a-b73e-41ee-80e3-2be036672bb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNf7af3b3a-b73e-41ee-80e3-2be036672bb7107
617312atorvastatin 10 MG Oral TabletSCDf7af3b3a-b73e-41ee-80e3-2be036672bb7107
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYf7af3b3a-b73e-41ee-80e3-2be036672bb7107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1710-17133517100130 TABLET, FILM COATED in 1 BOTTLE (71335-1710-1) 2021-02-030000-00-00NoNoCurrent
71335-1710-27133517100290 TABLET, FILM COATED in 1 BOTTLE (71335-1710-2) 2020-12-040000-00-00NoNoCurrent
71335-1710-37133517100360 TABLET, FILM COATED in 1 BOTTLE (71335-1710-3) 2024-05-300000-00-00NoNoCurrent
71335-1710-471335171004120 TABLET, FILM COATED in 1 BOTTLE (71335-1710-4) 2021-04-190000-00-00NoNoCurrent
71335-1710-571335171005100 TABLET, FILM COATED in 1 BOTTLE (71335-1710-5) 2021-11-190000-00-00NoNoCurrent
71335-1710-671335171006180 TABLET, FILM COATED in 1 BOTTLE (71335-1710-6) 2024-05-300000-00-00NoNoCurrent