FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71335-1126
11-digit product format
713351126
Labeler code
71335
Product ID
71335-1126_304d9a7c-00e9-48f8-ad99-21fc4575f188
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207687
Marketing category
ANDA
Marketing start
2018-08-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1126-12024-05-20C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-22024-05-20C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-32024-05-20C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-42024-05-20C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-52024-05-20C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-62024-05-20C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-12024-01-30C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-22024-01-30C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-32024-01-30C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-42024-01-30C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-52024-01-30C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996
71335-1126-62024-01-30C16284748780-11030e365-30fd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN calcium tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1126-1ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED307
71335-1126-2ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1007
71335-1126-3ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED907
71335-1126-4ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED607
71335-1126-5ATORVASTATIN CALCIUM180 in 1 BOTTLETABLET, FILM COATED1807
71335-1126-6ATORVASTATIN CALCIUM10 in 1 BOTTLETABLET, FILM COATED107
71335-1126-7ATORVASTATIN CALCIUM7 in 1 BOTTLETABLET, FILM COATED77

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1126ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 7 package rows20241116_1fb2d51e-360c-40a3-8072-f22893890a51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN1fb2d51e-360c-40a3-8072-f22893890a517
617311atorvastatin 40 MG Oral TabletSCD1fb2d51e-360c-40a3-8072-f22893890a517
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1fb2d51e-360c-40a3-8072-f22893890a517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1126-17133511260130 TABLET, FILM COATED in 1 BOTTLE (71335-1126-1) 2019-03-010000-00-00NoNoCurrent
71335-1126-271335112602100 TABLET, FILM COATED in 1 BOTTLE (71335-1126-2) 2024-10-310000-00-00NoNoCurrent
71335-1126-37133511260390 TABLET, FILM COATED in 1 BOTTLE (71335-1126-3) 2019-02-280000-00-00NoNoCurrent
71335-1126-47133511260460 TABLET, FILM COATED in 1 BOTTLE (71335-1126-4) 2024-10-310000-00-00NoNoCurrent
71335-1126-571335112605180 TABLET, FILM COATED in 1 BOTTLE (71335-1126-5) 2024-10-310000-00-00NoNoCurrent
71335-1126-67133511260610 TABLET, FILM COATED in 1 BOTTLE (71335-1126-6) 2024-10-310000-00-00NoNoCurrent
71335-1126-7713351126077 TABLET, FILM COATED in 1 BOTTLE (71335-1126-7) 2024-10-31NoNoHistorical