FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
50090-7532
11-digit product format
500907532
Labeler code
50090
Product ID
50090-7532_7b56301a-8200-43ef-862d-8cbcebc71527
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
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
50090-7532-0ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
50090-7532-1ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901
50090-7532-2ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7532-0EA - Each50090-753296a25602-4cd0-489a-bc4a-983998d0e85012025-05-14
50090-7532-1EA - Each50090-75329042afdd-3185-4aef-81da-8aeb3466344812025-05-14
50090-7532-2EA - Each50090-75324c871fbd-7730-4769-bec1-a8d3e6583d9512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7532ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20250417_766690b2-9784-4496-9cf3-d5584ae605de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN766690b2-9784-4496-9cf3-d5584ae605de1
259255atorvastatin 80 MG Oral TabletSCD766690b2-9784-4496-9cf3-d5584ae605de1
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY766690b2-9784-4496-9cf3-d5584ae605de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7532-05009075320030 TABLET, FILM COATED in 1 BOTTLE (50090-7532-0) 2025-04-08NoNoHistorical
50090-7532-15009075320190 TABLET, FILM COATED in 1 BOTTLE (50090-7532-1) 2025-04-08NoNoHistorical
50090-7532-250090753202100 TABLET, FILM COATED in 1 BOTTLE (50090-7532-2) 2025-04-08NoNoHistorical