MedPath
FDA Approval

Ibuprofen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen(100 mg in 5 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

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

Ibuprofen

Product Details

NDC Product Code
68071-2942
Application Number
ANDA076925
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 20, 2023
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6SClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 100 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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