Mefenamic Acid
Mefenamic Acid Capsules USPRx Only
Approved
Approval ID
d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mefenamic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-185
Application NumberANDA091322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mefenamic Acid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2024
FDA Product Classification
INGREDIENTS (13)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MEFENAMIC ACIDActive
Quantity: 250 mg in 1 1
Code: 367589PJ2C
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT