Atorvastatin Calcium

Product NDC
67296-1422
11-digit product format
672961422
Labeler code
67296
Product ID
67296-1422_bb684f3a-f31a-0e45-e053-2a95a90ac410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076477
Marketing category
ANDA
Marketing start
2021-02-15
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
2022-12-31
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
67296-1422-32026-01-29C16284748780-1f386c649-ab74-0266-e053-dadaa90a7c1aATORVASTATIN 20mg tab
67296-1422-32024-08-07C16284748780-1f386c649-ab74-0266-e053-dadaa90a7c1aATORVASTATIN 20mg tab
67296-1422-32023-01-30C16284748780-1f386c649-ab74-0266-e053-dadaa90a7c1aATORVASTATIN 20mg tab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1422-3Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1422ATORVASTATIN CALCIUM TABLET, FILM COATED [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20240808_bb684dda-15a4-6e6b-e053-2a95a90a8e53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNbb684dda-15a4-6e6b-e053-2a95a90a8e535
617310atorvastatin 20 MG Oral TabletSCDbb684dda-15a4-6e6b-e053-2a95a90a8e535
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYbb684dda-15a4-6e6b-e053-2a95a90a8e535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1422-36729614220330 TABLET, FILM COATED in 1 BOTTLE (67296-1422-3) 2021-02-150000-00-00NoNoCurrent