NDC 62135-480-49
API & Excipient Details

Cephalexin marketed by Chartwell RX, LLC under NDC Code 62135-480-49

NDC Code(s) : 62135-480-42, 62135-480-49, 62135-481-42, 62135-481-49
Packager : Chartwell RX, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CephalexinCephalexin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:62135-480
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CEPHALEXIN(UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)	CEPHALEXIN ANHYDROUS	125 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
STRAWBERRY(UNII: 4J2TY8Y81V)
METHYLCELLULOSE (25 CPS)(UNII: BI55GG2WLI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62135-480-42	100 mL in 1 BOTTLE Type 0: Not a Combination Product	02/01/2022
2	NDC:62135-480-49	200 mL in 1 BOTTLE Type 0: Not a Combination Product	02/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065336	02/28/2018

CephalexinCephalexin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:62135-481
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CEPHALEXIN(UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)	CEPHALEXIN ANHYDROUS	250 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
STRAWBERRY(UNII: 4J2TY8Y81V)
METHYLCELLULOSE (25 CPS)(UNII: BI55GG2WLI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62135-481-42	100 mL in 1 BOTTLE Type 0: Not a Combination Product	02/01/2022
2	NDC:62135-481-49	200 mL in 1 BOTTLE Type 0: Not a Combination Product	02/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065336	02/28/2018

LABELER - Chartwell RX, LLC(079394054)

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