FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
70934-091
11-digit product format
709340091
Labeler code
70934
Product ID
70934-091_b7def290-565c-7f4b-e053-2995a90abf2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA090548
Marketing category
ANDA
Marketing start
2018-03-26
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-091-302023-01-30C16284748780-1f386c64a-011a-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
70934-091-902023-01-30C16284748780-1f386c64a-011a-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
70934-091-30ATORVASTATIN CALCIUM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
70934-091-90ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-091-30EA - Each70934-091eda22984-2d98-42fa-a6e4-acdae591928a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-091ATORVASTATIN CALCIUM TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]4Legacy NDC, 2 package rows20210105_6eede7ca-0998-7038-e053-2991aa0a4e7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN6eede7ca-0998-7038-e053-2991aa0a4e7c4
617311atorvastatin 40 MG Oral TabletSCD6eede7ca-0998-7038-e053-2991aa0a4e7c4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY6eede7ca-0998-7038-e053-2991aa0a4e7c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-091-307093400913030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-091-30) 2018-03-260000-00-00NoNoCurrent
70934-091-907093400919090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-091-90) 2018-12-130000-00-00NoNoCurrent