NDC Code(s) : 24979-154-14, 24979-154-38, 24979-155-14, 24979-155-38
Packager : TWi Pharmaceuticals, Inc.

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:24979-154
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:24979-154-14100 mL in 1 BOTTLE Type 0: Not a Combination Product28/02/2018
2NDC:24979-154-38200 mL in 1 BOTTLE Type 0: Not a Combination Product28/02/2018
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: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
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:24979-155-14100 mL in 1 BOTTLE Type 0: Not a Combination Product28/02/2018
2NDC:24979-155-38200 mL in 1 BOTTLE Type 0: Not a Combination Product28/02/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065336 02/28/2018

LABELER - TWi Pharmaceuticals, Inc.(658402052)

REGISTRANT - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
Yung Shin Pharmaceutical Ind. Co., Ltd. 656108149 manufacture(24979-154, 24979-155), analysis(24979-154, 24979-155), pack(24979-154, 24979-155)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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