FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
50090-7386
11-digit product format
500907386
Labeler code
50090
Product ID
50090-7386_e8fb0195-46da-4f25-8cfd-b925a95c2415
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
2023-09-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVASTATIN CALCIUM
Listing expiration
2027-12-31

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
50090-7386-0ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED303
50090-7386-1ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED903
50090-7386-2ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7386-0EA - Each50090-73867e84941a-b607-41a5-a975-81412c483abd12024-12-10
50090-7386-1EA - Each50090-738640751712-d93b-4513-b660-e914645541cf12024-12-10
50090-7386-2EA - Each50090-738628d6873f-bff1-441d-b552-56786865eb2f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7386ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241024_db32eb1a-d282-47df-afa2-f250e3c67e71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNdb32eb1a-d282-47df-afa2-f250e3c67e713
617310atorvastatin 20 MG Oral TabletSCDdb32eb1a-d282-47df-afa2-f250e3c67e713
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYdb32eb1a-d282-47df-afa2-f250e3c67e713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7386-05009073860030 TABLET, FILM COATED in 1 BOTTLE (50090-7386-0) 2024-10-21NoNoHistorical
50090-7386-15009073860190 TABLET, FILM COATED in 1 BOTTLE (50090-7386-1) 2024-10-21NoNoHistorical
50090-7386-250090738602100 TABLET, FILM COATED in 1 BOTTLE (50090-7386-2) 2024-10-21NoNoHistorical