FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-1011
11-digit product format
713351011
Labeler code
71335
Product ID
71335-1011_b29b35b0-c718-4afe-b8ed-81bf3e1e0dae
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
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
71335-1011-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30104
71335-1011-2Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED100104
71335-1011-3Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90104
71335-1011-4Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60104
71335-1011-5Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180104
71335-1011-6Atorvastatin Calcium10 in 1 BOTTLETABLET, FILM COATED10104
71335-1011-7Atorvastatin Calcium7 in 1 BOTTLETABLET, FILM COATED7104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1011-3EA - Each71335-1011a5368e63-cc75-4026-be68-b5c705e4969712020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1011ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 7 package rows20240602_2e583569-499d-4f20-87ca-84e7d9868d22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN2e583569-499d-4f20-87ca-84e7d9868d22104
617311atorvastatin 40 MG Oral TabletSCD2e583569-499d-4f20-87ca-84e7d9868d22104
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2e583569-499d-4f20-87ca-84e7d9868d22104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1011-17133510110130 TABLET, FILM COATED in 1 BOTTLE (71335-1011-1) 2018-11-270000-00-00NoNoCurrent
71335-1011-271335101102100 TABLET, FILM COATED in 1 BOTTLE (71335-1011-2) 2024-05-300000-00-00NoNoCurrent
71335-1011-37133510110390 TABLET, FILM COATED in 1 BOTTLE (71335-1011-3) 2018-12-110000-00-00NoNoCurrent
71335-1011-47133510110460 TABLET, FILM COATED in 1 BOTTLE (71335-1011-4) 2024-05-300000-00-00NoNoCurrent
71335-1011-571335101105180 TABLET, FILM COATED in 1 BOTTLE (71335-1011-5) 2024-05-300000-00-00NoNoCurrent
71335-1011-67133510110610 TABLET, FILM COATED in 1 BOTTLE (71335-1011-6) 2024-05-300000-00-00NoNoCurrent
71335-1011-7713351011077 TABLET, FILM COATED in 1 BOTTLE (71335-1011-7) 2024-05-30NoNoHistorical