MedPath

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

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IBU - FDA Drug Approval Details