FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
50090-6057
11-digit product format
500906057
Labeler code
50090
Product ID
50090-6057_6127c13c-d9cc-46b7-883d-ebd3df07cee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207687
Marketing category
ANDA
Marketing start
2018-08-06
Marketing end
0000-00-00
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
2023-12-31
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
50090-6057-02024-01-30C16284748780-11030e365-098f-111a-e063-dadaa90a10e2These 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
50090-6057-12024-01-30C16284748780-11030e365-098f-111a-e063-dadaa90a10e2These 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
50090-6057-0ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED307
50090-6057-1ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6057-0EA - Each50090-6057be3aea90-e589-431c-9b81-757850027a2d12022-10-06
50090-6057-1EA - Each50090-60578d4de506-99ac-413a-acca-0e5037c8eecb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6057ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20220827_c4ec475d-8407-419c-b5e3-6b8dac17a79e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSNc4ec475d-8407-419c-b5e3-6b8dac17a79e7
259255atorvastatin 80 MG Oral TabletSCDc4ec475d-8407-419c-b5e3-6b8dac17a79e7
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYc4ec475d-8407-419c-b5e3-6b8dac17a79e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6057-05009060570030 TABLET, FILM COATED in 1 BOTTLE (50090-6057-0) 2022-08-250000-00-00NoNoCurrent
50090-6057-15009060570190 TABLET, FILM COATED in 1 BOTTLE (50090-6057-1) 2022-08-250000-00-00NoNoCurrent