Ibuprofen

Product NDC
83324-102
11-digit product format
833240102
Labeler code
83324
Product ID
83324-102_352e69a7-a1f7-85ad-e063-6394a90ad4d4
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
ANDA202312
Marketing category
ANDA
Marketing start
2025-05-15
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
83324-102-01833240102011 BOTTLE, PLASTIC in 1 CARTON (83324-102-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-15NoNoHistorical
83324-102-50833240102501 BOTTLE, PLASTIC in 1 CARTON (83324-102-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2025-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
QCH-1111C-2025-0515CHAIN DRUG MARKETING ASSOCIATION, INC.2025-05-15HUMAN OTC DRUG LABEL2