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
NDC Product Code62250-677
Application NumberANDA091608
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2023
Generic NameMefenamic Acid
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].