FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71335-1388
11-digit product format
713351388
Labeler code
71335
Product ID
71335-1388_be281412-b77c-459e-864d-db576e50cd87
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
2018-08-02
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1388-12024-05-20C16284748780-11030e365-38cf-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
71335-1388-22024-05-20C16284748780-11030e365-38cf-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
71335-1388-32024-05-20C16284748780-11030e365-38cf-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
71335-1388-42024-05-20C16284748780-11030e365-38cf-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
71335-1388-52024-05-20C16284748780-11030e365-38cf-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
71335-1388-62024-05-20C16284748780-11030e365-38cf-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
71335-1388-12024-01-30C16284748780-11030e365-38cf-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
71335-1388-22024-01-30C16284748780-11030e365-38cf-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
71335-1388-32024-01-30C16284748780-11030e365-38cf-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
71335-1388-42024-01-30C16284748780-11030e365-38cf-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
71335-1388-52024-01-30C16284748780-11030e365-38cf-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
71335-1388-62024-01-30C16284748780-11030e365-38cf-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
71335-1388-1ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED30102
71335-1388-2ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED90102
71335-1388-3ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED60102
71335-1388-4ATORVASTATIN CALCIUM120 in 1 BOTTLETABLET, FILM COATED120102
71335-1388-5ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED100102
71335-1388-6ATORVASTATIN CALCIUM180 in 1 BOTTLETABLET, FILM COATED180102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1388ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20241120_ace2c37e-b525-4fe7-8316-9bd3fa4a092c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNace2c37e-b525-4fe7-8316-9bd3fa4a092c102
617312atorvastatin 10 MG Oral TabletSCDace2c37e-b525-4fe7-8316-9bd3fa4a092c102
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYace2c37e-b525-4fe7-8316-9bd3fa4a092c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1388-17133513880130 TABLET, FILM COATED in 1 BOTTLE (71335-1388-1) 2019-11-040000-00-00NoNoCurrent
71335-1388-27133513880290 TABLET, FILM COATED in 1 BOTTLE (71335-1388-2) 2019-11-200000-00-00NoNoCurrent
71335-1388-37133513880360 TABLET, FILM COATED in 1 BOTTLE (71335-1388-3) 2024-10-310000-00-00NoNoCurrent
71335-1388-471335138804120 TABLET, FILM COATED in 1 BOTTLE (71335-1388-4) 2024-10-310000-00-00NoNoCurrent
71335-1388-571335138805100 TABLET, FILM COATED in 1 BOTTLE (71335-1388-5) 2020-10-060000-00-00NoNoCurrent
71335-1388-671335138806180 TABLET, FILM COATED in 1 BOTTLE (71335-1388-6) 2024-10-310000-00-00NoNoCurrent