Diflunisal

Product NDC
70771-1083
11-digit product format
707711083
Labeler code
70771
Product ID
70771-1083_d5395b92-79af-436c-82ac-a6b70cd3b139
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflunisal
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA203547
Marketing category
ANDA
Marketing start
2017-09-14
Substance
DIFLUNISAL
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diflunisal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFLUNISAL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7C546U4DEN
Rxcui197603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2323d3f0-80b8-7ff4-d997-b3ca46ce553aProduct name220170802

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1083-0Diflunisal1000 in 1 BOTTLETABLET10005
70771-1083-1Diflunisal100 in 1 BOTTLETABLET1005
70771-1083-3Diflunisal30 in 1 BOTTLETABLET305
70771-1083-5Diflunisal500 in 1 BOTTLETABLET5005
70771-1083-6Diflunisal60 in 1 BOTTLETABLET605
70771-1083-8Diflunisal10 in 1 BLISTER PACKTABLET105
70771-1083-8Diflunisal10 in 1 CARTONTABLET105
70771-1083-9Diflunisal90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1083DIFLUNISAL TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 8 package rows20241123_d7a722be-4612-4b2e-827d-56fb5eef0aae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197603diflunisal 500 MG Oral TabletPSNd7a722be-4612-4b2e-827d-56fb5eef0aae5
197603diflunisal 500 MG Oral TabletSCDd7a722be-4612-4b2e-827d-56fb5eef0aae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1083-0707711083001000 TABLET in 1 BOTTLE (70771-1083-0) 1000 tablet2017-09-140000-00-00NoNoCurrent
70771-1083-170771108301100 TABLET in 1 BOTTLE (70771-1083-1) 100 tablet2017-09-140000-00-00NoNoCurrent
70771-1083-37077110830330 TABLET in 1 BOTTLE (70771-1083-3) 30 tablet2017-09-140000-00-00NoNoCurrent
70771-1083-570771108305500 TABLET in 1 BOTTLE (70771-1083-5) 500 tablet2017-09-140000-00-00NoNoCurrent
70771-1083-67077110830660 TABLET in 1 BOTTLE (70771-1083-6) 60 tablet2017-09-140000-00-00NoNoCurrent
70771-1083-87077110830810 BLISTER PACK in 1 CARTON (70771-1083-8) / 10 TABLET in 1 BLISTER PACK10 blister pack2017-09-140000-00-00NoNoCurrent
70771-1083-97077110830990 TABLET in 1 BOTTLE (70771-1083-9) 90 tablet2017-09-140000-00-00NoNoCurrent