FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-2591
11-digit product format
713352591
Labeler code
71335
Product ID
71335-2591_11e721da-80b6-4730-ad52-ad11ec164696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209912
Marketing category
ANDA
Marketing start
2023-10-20
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
71335-2591-1Atorvastatin Calcium30 in 1 BOTTLETABLET302
71335-2591-2Atorvastatin Calcium100 in 1 BOTTLETABLET1002
71335-2591-3Atorvastatin Calcium90 in 1 BOTTLETABLET902
71335-2591-4Atorvastatin Calcium60 in 1 BOTTLETABLET602
71335-2591-5Atorvastatin Calcium180 in 1 BOTTLETABLET1802
71335-2591-6Atorvastatin Calcium10 in 1 BOTTLETABLET102
71335-2591-7Atorvastatin Calcium7 in 1 BOTTLETABLET72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN9c58c4cd-fe1c-4db7-832c-874766e4da212
617311atorvastatin 40 MG Oral TabletSCD9c58c4cd-fe1c-4db7-832c-874766e4da212
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY9c58c4cd-fe1c-4db7-832c-874766e4da212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2591-17133525910130 TABLET in 1 BOTTLE (71335-2591-1) 30 tablet2025-06-04NoNoHistorical
71335-2591-271335259102100 TABLET in 1 BOTTLE (71335-2591-2) 100 tablet2025-06-04NoNoHistorical
71335-2591-37133525910390 TABLET in 1 BOTTLE (71335-2591-3) 90 tablet2025-06-04NoNoHistorical
71335-2591-47133525910460 TABLET in 1 BOTTLE (71335-2591-4) 60 tablet2025-06-04NoNoHistorical
71335-2591-571335259105180 TABLET in 1 BOTTLE (71335-2591-5) 180 tablet2025-06-04NoNoHistorical
71335-2591-67133525910610 TABLET in 1 BOTTLE (71335-2591-6) 10 tablet2025-06-04NoNoHistorical
71335-2591-7713352591077 TABLET in 1 BOTTLE (71335-2591-7) 7 tablet2025-06-04NoNoHistorical