Ibuprofen

Product NDC
71205-464
11-digit product format
712050464
Labeler code
71205
Product ID
71205-464_8813a8a4-ebbd-4204-88a3-600a92ea9170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078329
Marketing category
ANDA
Marketing start
2018-08-24
Substance
IBUPROFEN
Active strength
400 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-464-157120504641515 TABLET, FILM COATED in 1 BOTTLE (71205-464-15) 2020-12-03NoNoHistorical
71205-464-207120504642020 TABLET, FILM COATED in 1 BOTTLE (71205-464-20) 2020-12-03NoNoHistorical
71205-464-307120504643030 TABLET, FILM COATED in 1 BOTTLE (71205-464-30) 2020-12-03NoNoHistorical
71205-464-607120504646060 TABLET, FILM COATED in 1 BOTTLE (71205-464-60) 2020-12-03NoNoHistorical
71205-464-907120504649090 TABLET, FILM COATED in 1 BOTTLE (71205-464-90) 2020-12-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ibuprofen tabletsProficient Rx LP2020-12-01HUMAN PRESCRIPTION DRUG LABEL1