ibuprofen

Product NDC
71205-787
11-digit product format
712050787
Labeler code
71205
Product ID
71205-787_4ee828df-873d-4379-9a17-a805d97dfe04
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA072096
Marketing category
ANDA
Marketing start
1994-08-16
Substance
IBUPROFEN
Active strength
200 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
71205-787-0071205078700100 TABLET, FILM COATED in 1 BOTTLE (71205-787-00) 2023-04-06NoNoHistorical
71205-787-307120507873030 TABLET, FILM COATED in 1 BOTTLE (71205-787-30) 2023-04-06NoNoHistorical
71205-787-607120507876060 TABLET, FILM COATED in 1 BOTTLE (71205-787-60) 2023-04-06NoNoHistorical
71205-787-907120507879090 TABLET, FILM COATED in 1 BOTTLE (71205-787-90) 2023-04-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Major Pharmaceuticals Ibuprofen Tablets, 200mg Drug FactsProficient Rx LP2023-04-01HUMAN OTC DRUG LABEL1