NDC Code(s) : 57237-032-50, 57237-032-75, 57237-032-01, 57237-033-50, 57237-033-75, 57237-033-01
Packager : Rising Pharma Holdings, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin Amoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-032
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
SUCROSE(UNII: C151H8M554)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SODIUM BENZOATE(UNII: OJ245FE5EU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
XANTHAN GUM(UNII: TTV12P4NEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color PINK Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-032-5050 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2006
2NDC:57237-032-7575 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2006
3NDC:57237-032-01100 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065334 12/28/2006
Amoxicillin Amoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:57237-033
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
SUCROSE(UNII: C151H8M554)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SODIUM BENZOATE(UNII: OJ245FE5EU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
XANTHAN GUM(UNII: TTV12P4NEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color PINK Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57237-033-5050 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2006
2NDC:57237-033-7575 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2006
3NDC:57237-033-01100 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065334 12/28/2006

LABELER - Rising Pharma Holdings, Inc.(116880195)

REGISTRANT - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917683 ANALYSIS(57237-032, 57237-033), MANUFACTURE(57237-032, 57237-033)

PRINCIPAL DISPLAY PANEL


Rising®    NDC 57237-032-01

Amoxicillin for Oral Suspension, USP
200 mg/5 mL
When reconstituted, each 5 mL contains:
AMOXICILLIN, 200 mg as the trihydrate

100 mL (when         Rx only
reconstituted)      
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/5 mL (100 mL Bottle)
 


 

PRINCIPAL DISPLAY PANEL


Rising®        NDC 57237-033-01

Amoxicillin for Oral Suspension, USP
400 mg/5 mL 

When reconstituted, each 5 mL contains:
AMOXICILLIN, 400 mg as the trihydrate

100 mL (when            Rx only
reconstituted)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg/5 mL (100 mL Bottle)