ATORVASTATIN CALCIUM

Product NDC
50090-6505
11-digit product format
500906505
Labeler code
50090
Product ID
50090-6505_0890b677-17fa-4b42-a3b1-f23563cea713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090548
Marketing category
ANDA
Marketing start
2021-08-01
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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 PROPYLENE GLYCOL SOLVATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui259255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6505-0ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
50090-6505-1ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901
50090-6505-2ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6505ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231206_7afe2137-b8b6-4506-818a-e5fadb2aee51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN7afe2137-b8b6-4506-818a-e5fadb2aee511
259255atorvastatin 80 MG Oral TabletSCD7afe2137-b8b6-4506-818a-e5fadb2aee511
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY7afe2137-b8b6-4506-818a-e5fadb2aee511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6505-05009065050030 TABLET, FILM COATED in 1 BOTTLE (50090-6505-0) 2023-05-30NoNoCurrent
50090-6505-15009065050190 TABLET, FILM COATED in 1 BOTTLE (50090-6505-1) 2023-05-30NoNoCurrent
50090-6505-250090650502100 TABLET, FILM COATED in 1 BOTTLE (50090-6505-2) 2023-05-30NoNoCurrent