FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71335-2407
11-digit product format
713352407
Labeler code
71335
Product ID
71335-2407_eb54dbcf-ee31-4ce3-9864-f19063a687ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214344
Marketing category
ANDA
Marketing start
2023-09-12
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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 TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255

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
71335-2407-1ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED305
71335-2407-2ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED605
71335-2407-3ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED905
71335-2407-4ATORVASTATIN CALCIUM180 in 1 BOTTLETABLET, FILM COATED1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2407ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, 4 package rows20250123_49e0e9e7-447d-4d9d-847e-46d68a77db2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN49e0e9e7-447d-4d9d-847e-46d68a77db2d5
259255atorvastatin 80 MG Oral TabletSCD49e0e9e7-447d-4d9d-847e-46d68a77db2d5
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY49e0e9e7-447d-4d9d-847e-46d68a77db2d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2407-17133524070130 TABLET, FILM COATED in 1 BOTTLE (71335-2407-1) 2024-09-10NoNoHistorical
71335-2407-27133524070260 TABLET, FILM COATED in 1 BOTTLE (71335-2407-2) 2024-11-01NoNoHistorical
71335-2407-37133524070390 TABLET, FILM COATED in 1 BOTTLE (71335-2407-3) 2024-05-29NoNoHistorical
71335-2407-471335240704180 TABLET, FILM COATED in 1 BOTTLE (71335-2407-4) 2024-11-01NoNoHistorical