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FDA Approval

Cephalexin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
RedPharm Drug Inc.
DUNS: 008039641
Effective Date
July 6, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cephalexin(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

LUPIN LIMITED

RedPharm Drug Inc.

725504448

Products1

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

Cephalexin

Product Details

NDC Product Code
67296-0320
Application Number
ANDA065229
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 6, 2011
GELATINInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: OBN7UDS42YClass: ACTIMQuantity: 500 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
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