FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
71335-9711
11-digit product format
713359711
Labeler code
71335
Product ID
71335-9711_6a143158-ec27-492c-ba6b-0dbacabc74bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin calcium
Listing expiration
2027-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9711-1Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED30104
71335-9711-2Atorvastatin calcium100 in 1 BOTTLETABLET, FILM COATED100104
71335-9711-3Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED90104
71335-9711-4Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED60104
71335-9711-5Atorvastatin calcium180 in 1 BOTTLETABLET, FILM COATED180104
71335-9711-6Atorvastatin calcium10 in 1 BOTTLETABLET, FILM COATED10104
71335-9711-7Atorvastatin calcium7 in 1 BOTTLETABLET, FILM COATED7104
71335-9711-8Atorvastatin calcium20 in 1 BOTTLETABLET, FILM COATED20104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9711-3EA - Each71335-9711de621c22-3c30-4c58-9a0b-7d159edb7d2e12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9711ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 8 package rows20240823_bf35034d-27ab-4263-a9ed-c7cee1a4fb0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSNbf35034d-27ab-4263-a9ed-c7cee1a4fb0a104
617311atorvastatin 40 MG Oral TabletSCDbf35034d-27ab-4263-a9ed-c7cee1a4fb0a104
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYbf35034d-27ab-4263-a9ed-c7cee1a4fb0a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9711-17133597110130 TABLET, FILM COATED in 1 BOTTLE (71335-9711-1) 2023-06-26NoNoHistorical
71335-9711-271335971102100 TABLET, FILM COATED in 1 BOTTLE (71335-9711-2) 2024-07-16NoNoHistorical
71335-9711-37133597110390 TABLET, FILM COATED in 1 BOTTLE (71335-9711-3) 2023-05-12NoNoHistorical
71335-9711-47133597110460 TABLET, FILM COATED in 1 BOTTLE (71335-9711-4) 2024-07-16NoNoHistorical
71335-9711-571335971105180 TABLET, FILM COATED in 1 BOTTLE (71335-9711-5) 2024-07-16NoNoHistorical
71335-9711-67133597110610 TABLET, FILM COATED in 1 BOTTLE (71335-9711-6) 2024-07-16NoNoHistorical
71335-9711-7713359711077 TABLET, FILM COATED in 1 BOTTLE (71335-9711-7) 2024-07-16NoNoHistorical
71335-9711-87133597110820 TABLET, FILM COATED in 1 BOTTLE (71335-9711-8) 2024-07-16NoNoHistorical