MedPath

Ibuprofen

Ibuprofen 600MG

Approved
Approval ID

a2f34915-4898-3a6e-e053-2a95a90a56a8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 9, 2023

Manufacturers
FDA

RedPharm Drug, Inc.

DUNS: 828374897

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ibuprofen

PRODUCT DETAILS

NDC Product Code67296-1757
Application NumberANDA078329
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 9, 2023
Generic NameIbuprofen

INGREDIENTS (11)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
IBUPROFENActive
Quantity: 600 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

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Ibuprofen - FDA Drug Approval Details