FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
50090-7528
11-digit product format
500907528
Labeler code
50090
Product ID
50090-7528_f8c0aec8-f520-4b57-ae5b-68c354285392
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
20 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 TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310

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
50090-7528-0ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
50090-7528-1ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901
50090-7528-2ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7528-0EA - Each50090-7528ed8f59bf-684e-4db2-b417-560f7613299e12025-05-14
50090-7528-1EA - Each50090-75286341eb55-307b-4fbe-b3c1-0a4e489b5c5912025-05-14
50090-7528-2EA - Each50090-75286c49ffc2-309e-414f-8317-0931c4e9b85512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7528ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20250417_fff3e5db-d15f-4eb0-b9ed-7961b4e078e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNfff3e5db-d15f-4eb0-b9ed-7961b4e078e41
617310atorvastatin 20 MG Oral TabletSCDfff3e5db-d15f-4eb0-b9ed-7961b4e078e41
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYfff3e5db-d15f-4eb0-b9ed-7961b4e078e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7528-05009075280030 TABLET, FILM COATED in 1 BOTTLE (50090-7528-0) 2025-04-07NoNoHistorical
50090-7528-15009075280190 TABLET, FILM COATED in 1 BOTTLE (50090-7528-1) 2025-04-07NoNoHistorical
50090-7528-250090752802100 TABLET, FILM COATED in 1 BOTTLE (50090-7528-2) 2025-04-07NoNoHistorical