Diflunisal

Product NDC
0093-0755
11-digit product format
000930755
Labeler code
0093
Product ID
0093-0755_8b62b5af-d2a9-4d06-a78b-23f92523c19f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflunisal
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA073673
Marketing category
ANDA
Marketing start
1992-11-01
Marketing end
2022-08-31
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0755-01EA - Each0093-075560e52851-1c2c-4ee4-a9b6-c8b8f155fe2b12012-07-24
0093-0755-05EA - Each0093-0755a260b411-8906-4daa-b561-54b77241669712012-07-24
0093-0755-06EA - Each0093-075509da708a-0c62-41ee-a0c1-d4f7474d9da212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIFLUNISALACTIVE INGREDIENT7C546U4DENDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
DIFLUNISALACTIVE MOIETY7C546U4DENDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
DIFLUNISALACTIVE INGREDIENT7C546U4DENDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
DIFLUNISALACTIVE MOIETY7C546U4DENDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197603diflunisal 500 MG Oral TabletPSN3baf108a-e9c1-4a2a-8e69-34aa69af1de34
197603diflunisal 500 MG Oral TabletPSNea8ce5e2-dad4-4288-a1e1-775ea98a6fb94
197603diflunisal 500 MG Oral TabletSCD3baf108a-e9c1-4a2a-8e69-34aa69af1de34
197603diflunisal 500 MG Oral TabletSCDea8ce5e2-dad4-4288-a1e1-775ea98a6fb94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-0755-0100093075501100 TABLET, FILM COATED in 1 BOTTLE (0093-0755-01) 1992-11-010000-00-00NoNoCurrent
0093-0755-0500093075505500 TABLET, FILM COATED in 1 BOTTLE (0093-0755-05) 1992-11-010000-00-00NoNoCurrent
0093-0755-060009307550660 TABLET, FILM COATED in 1 BOTTLE (0093-0755-06) 1992-11-012022-08-31NoNoCurrent