FDA.reportPublic FDA data

DIFLUNISAL

Product NDC
52959-379
11-digit product format
529590379
Labeler code
52959
Product ID
52959-379_60e0ecab-9d00-3b1b-e053-2a91aa0af663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIFLUNISAL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H. J. Harkins Company Inc.
Application
ANDA073673
Marketing category
ANDA
Marketing start
2017-12-22
Marketing end
0000-00-00
Substance
DIFLUNISAL
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
2323d3f0-80b8-7ff4-d997-b3ca46ce553aProduct name220170802

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-379-142020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-152020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-202020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-212020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-302020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-602020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663
52959-379-902020-01-31C16284748780-19d75b9d0-438d-f424-e053-dadaa90a57ce60e0ecab-9cff-3b1b-e053-2a91aa0af663

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-379-14DIFLUNISAL14 in 1 CONTAINERTABLET, FILM COATED141
52959-379-15DIFLUNISAL15 in 1 CONTAINERTABLET, FILM COATED151
52959-379-20DIFLUNISAL20 in 1 CONTAINERTABLET, FILM COATED201
52959-379-21DIFLUNISAL21 in 1 CONTAINERTABLET, FILM COATED211
52959-379-30DIFLUNISAL30 in 1 CONTAINERTABLET, FILM COATED301
52959-379-60DIFLUNISAL60 in 1 CONTAINERTABLET, FILM COATED601
52959-379-90DIFLUNISAL90 in 1 CONTAINERTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-379-15EA - Each52959-3790aa2aa86-b8b5-4957-abe0-c9c95bfedec412018-01-12
52959-379-20EA - Each52959-379ddd4dc1d-10e6-4412-b6ef-e5d6357c905712018-01-12
52959-379-30EA - Each52959-3796fedd03c-8259-4d37-8274-12033a21fb3c12018-01-12
52959-379-60EA - Each52959-379d73e2382-f339-44a2-88f6-8ed95548b5b212018-01-12
52959-379-90EA - Each52959-3790d079ff4-63dc-46e5-96b0-bf9747250a6712018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-379DIFLUNISAL TABLET, FILM COATED [H. J. HARKINS COMPANY INC.]1Legacy NDC, 7 package rows20171222_60e0ecab-9cff-3b1b-e053-2a91aa0af663.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197603diflunisal 500 MG Oral TabletPSN60e0ecab-9cff-3b1b-e053-2a91aa0af6631
197603diflunisal 500 MG Oral TabletSCD60e0ecab-9cff-3b1b-e053-2a91aa0af6631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-379-145295903791414 in 1 CONTAINERHistorical
52959-379-155295903791515 in 1 CONTAINERHistorical
52959-379-205295903792020 in 1 CONTAINERHistorical
52959-379-215295903792121 in 1 CONTAINERHistorical
52959-379-305295903793030 in 1 CONTAINERHistorical
52959-379-605295903796060 in 1 CONTAINERHistorical
52959-379-905295903799090 in 1 CONTAINERHistorical