FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
50090-3536
11-digit product format
500903536
Labeler code
50090
Product ID
50090-3536_2cab0ff3-067b-4868-bfa4-42dfd7f99537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3536-02023-01-30C16284748780-1f386c64a-03a9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin calcium tablets for oral use Initial U.S. Approval: 1996
50090-3536-12023-01-30C16284748780-1f386c64a-03a9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin calcium tablets for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3536-0Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED302
50090-3536-1Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3536ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20190531_8a501779-5774-46d9-b3e6-19fdbfbd9344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN8a501779-5774-46d9-b3e6-19fdbfbd93442
617310atorvastatin 20 MG Oral TabletSCD8a501779-5774-46d9-b3e6-19fdbfbd93442
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY8a501779-5774-46d9-b3e6-19fdbfbd93442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3536-05009035360030 TABLET, FILM COATED in 1 BOTTLE (50090-3536-0) 2018-09-100000-00-00NoNoCurrent
50090-3536-15009035360190 TABLET, FILM COATED in 1 BOTTLE (50090-3536-1) 2018-08-140000-00-00NoNoCurrent