NDC 53002-1369-3
API & Excipient Details

Amoxicillin Trihydrate marketed by RPK Pharmaceuticals, Inc. under NDC Code 53002-1369-3

NDC Code(s) : 53002-1369-3, 53002-2090-3, 53002-2090-1, 53002-2090-2
Packager : RPK Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53002-1369(NDC:0781-6157)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	400 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53002-1369-3	100 mL in 1 BOTTLE Type 0: Not a Combination Product	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065378	03/26/2007

AmoxicillinAmoxicillin POWDER, FOR SUSPENSION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53002-2090(NDC:0781-6041)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	250 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53002-2090-3	150 mL in 1 BOTTLE Type 0: Not a Combination Product	10/01/2018
2	NDC:53002-2090-1	80 mL in 1 BOTTLE Type 0: Not a Combination Product	10/01/2018
3	NDC:53002-2090-2	100 mL in 1 BOTTLE Type 0: Not a Combination Product	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA065387	03/26/2007

LABELER - RPK Pharmaceuticals, Inc.(147096275)

Establishment
Name	Address	ID/FEI	Business Operations
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-1369, 53002-2090)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL