ATORVASTATIN CALCIUM

Product NDC
61919-303
11-digit product format
619190303
Labeler code
61919
Product ID
61919-303_b8556fd4-1769-6175-e053-2995a90aaf6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090548
Marketing category
ANDA
Marketing start
2018-11-09
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
61919-303-902023-01-30C16284748780-1f386c649-9e9b-0266-e053-dadaa90a7c1aATORVASTATIN CALCIUM
61919-303-302020-01-31C16284748780-19d75b9d0-c148-f424-e053-dadaa90a57ceATORVASTATIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-303-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED903
61919-303-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-303-30EA - Each61919-303576da26d-c93b-4e91-ba82-a7f415545a5712018-04-19
61919-303-90EA - Each61919-3032ee6c746-1e4e-4bd1-b7d1-bdfb53618ace12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-303ATORVASTATIN CALCIUM (ATORVASTATIN) TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20210108_7a3d0c78-f0a7-0706-e053-2991aa0ae9f7.zip
61919-303ATORVASTATIN CALCIUM (ATORVASTATIN) TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20180315_339af810-2a32-0804-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN7a3d0c78-f0a7-0706-e053-2991aa0ae9f73
617311atorvastatin 40 MG Oral TabletSCD7a3d0c78-f0a7-0706-e053-2991aa0ae9f73
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7a3d0c78-f0a7-0706-e053-2991aa0ae9f73
617311atorvastatin calcium 40 MG Oral TabletPSN339af810-2a32-0804-e054-00144ff8d46c2
617311atorvastatin 40 MG Oral TabletSCD339af810-2a32-0804-e054-00144ff8d46c2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY339af810-2a32-0804-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-303-306191903033030 in 1 BOTTLEHistorical
61919-303-906191903039090 TABLET, FILM COATED in 1 BOTTLE (61919-303-90) 2018-11-090000-00-00NoNoCurrent