NDC Code(s) : 0143-9886-01, 0143-9886-50, 0143-9886-75, 0143-9887-01, 0143-9887-50, 0143-9887-75
Packager : Hikma Pharmaceuticals USA 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:0143-9886
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCROSE(UNII: C151H8M554)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9886-01100 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2006
2NDC:0143-9886-5050 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2006
3NDC:0143-9886-7575 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065325 06/19/2006
AmoxicillinAmoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9887
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCROSE(UNII: C151H8M554)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0143-9887-01100 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2006
2NDC:0143-9887-5050 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2006
3NDC:0143-9887-7575 mL in 1 BOTTLE Type 0: Not a Combination Product19/06/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065325 06/19/2006

LABELER - Hikma Pharmaceuticals USA Inc.(001230762)

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 0143-9886-01

Amoxicillin
For Oral Suspension, USP
Dye Free
200 mg/5 mL*
100 mL (when reconstituted)
WARNING: NOT FOR INJECTION
Rx Only

Amoxicillin OS 200 mg/5 mL (100 mL) bottle label image

PRINCIPAL DISPLAY PANEL

Principal Display Panel
NDC 0143-9887-01

Amoxicillin
For Oral Suspension, USP
Dye Free
400 mg/5 mL*
100 mL (when reconstituted)
WARNING: NOT FOR INJECTION
Rx Only

Amoxicillin OS 400 mg/5 mL (100 mL) bottle label image