FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
71335-9646
11-digit product format
713359646
Labeler code
71335
Product ID
71335-9646_7218b0fa-38bf-43ed-b851-94e0e26ebb09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213853
Marketing category
ANDA
Marketing start
2020-08-26
Substance
ATORVASTATIN
Active strength
80 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
ATORVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
Rxcui259255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-9646-1Atorvastatin calcium30 in 1 BOTTLETABLET30105
71335-9646-2Atorvastatin calcium60 in 1 BOTTLETABLET60105
71335-9646-3Atorvastatin calcium90 in 1 BOTTLETABLET90105
71335-9646-4Atorvastatin calcium180 in 1 BOTTLETABLET180105
71335-9646-5Atorvastatin calcium100 in 1 BOTTLETABLET100105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9646ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, 5 package rows20250303_112ae40c-b612-405b-8f68-6d4bf09f9440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN112ae40c-b612-405b-8f68-6d4bf09f9440105
259255atorvastatin 80 MG Oral TabletSCD112ae40c-b612-405b-8f68-6d4bf09f9440105
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY112ae40c-b612-405b-8f68-6d4bf09f9440105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9646-17133596460130 TABLET in 1 BOTTLE (71335-9646-1) 30 tablet2023-06-29NoNoHistorical
71335-9646-27133596460260 TABLET in 1 BOTTLE (71335-9646-2) 60 tablet2026-04-13NoNoHistorical
71335-9646-37133596460390 TABLET in 1 BOTTLE (71335-9646-3) 90 tablet2023-02-09NoNoHistorical
71335-9646-471335964604180 TABLET in 1 BOTTLE (71335-9646-4) 180 tablet2026-04-13NoNoHistorical
71335-9646-571335964605100 TABLET in 1 BOTTLE (71335-9646-5) 100 tablet2026-04-13NoNoHistorical