Dolobid

Product NDC
74157-101
11-digit product format
741570101
Labeler code
74157
Product ID
74157-101_4081e337-1003-6e39-e063-6294a90a4698
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflunisal
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
INA Pharmaceutics Inc
Application
ANDA202845
Marketing category
ANDA
Marketing start
2024-08-19
Substance
DIFLUNISAL
Active strength
375 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
Dolobid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFLUNISAL375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7C546U4DEN
Rxcui105823, 197602, 249400, 2691103

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
74157-101-60Dolobid60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74157-101DOLOBID (DIFLUNISAL) TABLET, FILM COATED [INA PHARMACEUTICS INC]3Current NDC, 1 package rows20240829_725234b2-0e23-45c3-a42d-eb4e62273f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197602diflunisal 250 MG Oral TabletPSN725234b2-0e23-45c3-a42d-eb4e62273f9b4
249400diflunisal 375 MG Oral TabletPSN725234b2-0e23-45c3-a42d-eb4e62273f9b4
105823DOLOBID 250 MG Oral TabletPSN725234b2-0e23-45c3-a42d-eb4e62273f9b4
2691103DOLOBID 375 MG Oral TabletPSN725234b2-0e23-45c3-a42d-eb4e62273f9b4
105823diflunisal 250 MG Oral Tablet [Dolobid]SBD725234b2-0e23-45c3-a42d-eb4e62273f9b4
2691103diflunisal 375 MG Oral Tablet [Dolobid]SBD725234b2-0e23-45c3-a42d-eb4e62273f9b4
197602diflunisal 250 MG Oral TabletSCD725234b2-0e23-45c3-a42d-eb4e62273f9b4
249400diflunisal 375 MG Oral TabletSCD725234b2-0e23-45c3-a42d-eb4e62273f9b4
105823Dolobid 250 MG Oral TabletSY725234b2-0e23-45c3-a42d-eb4e62273f9b4
2691103Dolobid 375 MG Oral TabletSY725234b2-0e23-45c3-a42d-eb4e62273f9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
74157-101-607415701016060 TABLET, FILM COATED in 1 BOTTLE (74157-101-60) 2024-08-19NoNoCurrent