Ibuprofen minis
Drug Facts
Approved
Approval ID
e9dad35a-6789-42d6-97da-521db7b16496
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 24, 2025
Manufacturers
FDA
WR Group, Inc.
DUNS: 089173699
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69607-8438
Application NumberANDA206568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2025
FDA Product Classification
INGREDIENTS (9)
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT