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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53002-1369-3100 mL in 1 BOTTLE Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53002-2090-3150 mL in 1 BOTTLE Type 0: Not a Combination Product10/01/2018
2NDC:53002-2090-180 mL in 1 BOTTLE Type 0: Not a Combination Product10/01/2018
3NDC:53002-2090-2100 mL in 1 BOTTLE Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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

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PRINCIPAL DISPLAY PANEL

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