NDC Code(s) : 61919-798-32
Packager : DIRECTRX

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CEPHALEXIN ORAL SUSPCEPHALEXIN ORAL SUSP POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-798(NDC:24979-155)
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
SUCROSE(UNII: C151H8M554)
FD&C RED NO. 40(UNII: WZB9127XOA)
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:61919-798-32100 mL in 1 BOTTLE Type 0: Not a Combination Product04/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065152 04/03/2019

LABELER - DIRECTRX(079254320)

Establishment
Name Address ID/FEI Business Operations
DIRECTRX 079254320 relabel(61919-798)

PRINCIPAL DISPLAY PANEL

798-32