Mefenamic Acid
Mefenamic Acid Capsules USP, 250 mg
Approved
Approval ID
4c275df4-f044-4867-8498-f46d34103bbb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Belcher Pharmaceuticals,LLC
DUNS: 965082543
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 Code62250-677
Application NumberANDA091608
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mefenamic Acid
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
MEFENAMIC ACIDActive
Quantity: 250 mg in 1 1
Code: 367589PJ2C
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Drug Labeling Information
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 6/24/2015
HOW SUPPLIED
Mefenamic acid is available as 250 mg green-banded, yellow capsules, imprinted with "BP" on the cap and "629" on the body in green ink. Bottles of 30, NDC# 62250-677-30.
Dispense in a tight container as defined in the USP.
Storage
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].