FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71335-1507
11-digit product format
713351507
Labeler code
71335
Product ID
71335-1507_7fff292f-dba8-4613-a8d0-19ea6cd0e6a8
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
20 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 TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310

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
71335-1507-1ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED30102
71335-1507-2ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED60102
71335-1507-3ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED90102
71335-1507-4ATORVASTATIN CALCIUM9 in 1 BOTTLETABLET, FILM COATED9102
71335-1507-5ATORVASTATIN CALCIUM28 in 1 BOTTLETABLET, FILM COATED28102
71335-1507-6ATORVASTATIN CALCIUM20 in 1 BOTTLETABLET, FILM COATED20102
71335-1507-7ATORVASTATIN CALCIUM180 in 1 BOTTLETABLET, FILM COATED180102
71335-1507-8ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED100102
71335-1507-9ATORVASTATIN CALCIUM7 in 1 BOTTLETABLET, FILM COATED7102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1507ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20241120_cbeb2aa0-24a2-430f-b456-34a4e63e1817.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNcbeb2aa0-24a2-430f-b456-34a4e63e1817102
617310atorvastatin 20 MG Oral TabletSCDcbeb2aa0-24a2-430f-b456-34a4e63e1817102
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYcbeb2aa0-24a2-430f-b456-34a4e63e1817102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1507-17133515070130 TABLET, FILM COATED in 1 BOTTLE (71335-1507-1) 2020-02-100000-00-00NoNoCurrent
71335-1507-27133515070260 TABLET, FILM COATED in 1 BOTTLE (71335-1507-2) 2020-03-160000-00-00NoNoCurrent
71335-1507-37133515070390 TABLET, FILM COATED in 1 BOTTLE (71335-1507-3) 2020-02-250000-00-00NoNoCurrent
71335-1507-4713351507049 TABLET, FILM COATED in 1 BOTTLE (71335-1507-4) 2024-10-310000-00-00NoNoCurrent
71335-1507-57133515070528 TABLET, FILM COATED in 1 BOTTLE (71335-1507-5) 2024-10-310000-00-00NoNoCurrent
71335-1507-67133515070620 TABLET, FILM COATED in 1 BOTTLE (71335-1507-6) 2024-10-310000-00-00NoNoCurrent
71335-1507-771335150707180 TABLET, FILM COATED in 1 BOTTLE (71335-1507-7) 2024-10-310000-00-00NoNoCurrent
71335-1507-871335150708100 TABLET, FILM COATED in 1 BOTTLE (71335-1507-8) 2024-10-31NoNoHistorical
71335-1507-9713351507097 TABLET, FILM COATED in 1 BOTTLE (71335-1507-9) 2024-10-31NoNoHistorical