FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
50090-7574
11-digit product format
500907574
Labeler code
50090
Product ID
50090-7574_f60dbfa3-ccc0-494e-936f-75aa65b2553a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214344
Marketing category
ANDA
Marketing start
2024-10-01
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

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
50090-7574-0ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
50090-7574-1ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901
50090-7574-2ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7574-0EA - Each50090-75742ca97f8d-70e0-4c16-b2d4-d211f928b38712025-07-08
50090-7574-1EA - Each50090-7574ca253ae2-5bc1-45e4-a146-9687097232bf12025-07-08
50090-7574-2EA - Each50090-7574cf8c18e9-090a-4f0a-8481-60736be5c68f12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN2f84fd12-3e13-47b0-a628-d22a7c4ac3c01
617312atorvastatin 10 MG Oral TabletSCD2f84fd12-3e13-47b0-a628-d22a7c4ac3c01
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2f84fd12-3e13-47b0-a628-d22a7c4ac3c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7574-05009075740030 TABLET, FILM COATED in 1 BOTTLE (50090-7574-0) 2025-06-09NoNoCurrent
50090-7574-15009075740190 TABLET, FILM COATED in 1 BOTTLE (50090-7574-1) 2025-06-09NoNoCurrent
50090-7574-250090757402100 TABLET, FILM COATED in 1 BOTTLE (50090-7574-2) 2025-06-09NoNoCurrent