IBU
IBU Tablets
Approved
Approval ID
e25dd2e8-a1d4-4098-9b8a-c20a635969d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-3370
Application NumberANDA075682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2019
FDA Product Classification
INGREDIENTS (11)
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
IBUPROFENActive
Quantity: 400 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT