MedPath

Cephalexin

CEPHALEXIN CAPSULES, USP

Approved
Approval ID

8494bec5-8404-43e4-bfa1-a7270b8dfbf7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

Belcher Pharmaceuticals, LLC

DUNS: 965082543

Products 2

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

Cephalexin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62250-801
Application NumberANDA062713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEPHALEXINActive
Quantity: 250 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM

Cephalexin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62250-802
Application NumberANDA062713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cephalexin - FDA Drug Approval Details