Mefenamic Acid
Mefenamic Acid
Approved
Approval ID
d0291319-ab3e-20c8-e053-2a95a90afabb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2022
Manufacturers
FDA
Misemer Pharmaceuticals, Inc
DUNS: 784121365
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 Code0276-0509
Application NumberANDA091608
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mefenamic Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2022
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
MEFENAMIC ACIDActive
Quantity: 250 mg in 1 1
Code: 367589PJ2C
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT