Atorvastatin Calcium

Product NDC
61919-956
11-digit product format
619190956
Labeler code
61919
Product ID
61919-956_f21620df-a19a-7df4-e053-2995a90a00c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091624
Marketing category
ANDA
Marketing start
2019-01-18
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-956-902025-01-30C16284748780-12cef2736-b30e-d83d-e063-dadaa90ab31fAtorvastatin Calcium
61919-956-302020-01-31C16284748780-19d75b9d0-5587-f424-e053-dadaa90a57ceATORVASTATIN CALCIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-956-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED904
61919-956-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-956-30EA - Each61919-956db613dbe-7e43-47cd-b517-f5afdae647f112017-04-05
61919-956-90EA - Each61919-956ef7eaaa3-eba9-41fe-beb8-4ea65f6b561d12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-956ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 1 package rows20230113_7fbc356a-ce53-68a2-e053-2991aa0a04d4.zip
61919-956ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECT RX]1Legacy NDC, 1 package rows20170213_4636ca02-79c3-5a35-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN7fbc356a-ce53-68a2-e053-2991aa0a04d44
617312atorvastatin 10 MG Oral TabletSCD7fbc356a-ce53-68a2-e053-2991aa0a04d44
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY7fbc356a-ce53-68a2-e053-2991aa0a04d44
617312atorvastatin calcium 10 MG Oral TabletPSN4636ca02-79c3-5a35-e054-00144ff8d46c1
617312atorvastatin 10 MG Oral TabletSCD4636ca02-79c3-5a35-e054-00144ff8d46c1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY4636ca02-79c3-5a35-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-956-306191909563030 in 1 BOTTLEHistorical
61919-956-906191909569090 TABLET, FILM COATED in 1 BOTTLE (61919-956-90) 2019-01-180000-00-00NoNoCurrent