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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN(UNII: OBN7UDS42Y)
(CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677) 		CEPHALEXIN ANHYDROUS125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
STRAWBERRY(UNII: 4J2TY8Y81V)
METHYLCELLULOSE (25 CPS)(UNII: BI55GG2WLI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62135-480-42100 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2022
2NDC:62135-480-49200 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN(UNII: OBN7UDS42Y)
(CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677) 		CEPHALEXIN ANHYDROUS250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
STRAWBERRY(UNII: 4J2TY8Y81V)
METHYLCELLULOSE (25 CPS)(UNII: BI55GG2WLI)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62135-481-42100 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2022
2NDC:62135-481-49200 mL in 1 BOTTLE Type 0: Not a Combination Product02/01/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065336 02/28/2018

LABELER - Chartwell RX, LLC(079394054)

PRINCIPAL DISPLAY PANEL

CEPHALEXIN for oral suspension USP - NDC 62135-480-42 - 125mg/5mL - 100 mL Bottle Label

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CEPHALEXIN for oral suspension USP - NDC 62135-480-49 - 125mg/5mL - 200 mL Bottle Label

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CEPHALEXIN for oral suspension USP - NDC 62135-481-42 - 250mg/5mL - 100 mL Bottle Label

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CEPHALEXIN for oral suspension USP - NDC 62135-481-49 - 250mg/5mL - 200 mL Bottle Label

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