Azithromycin Monohydrate (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 65162-708-83
Azithromycin for oral suspension USP, 100 mg/5 mL
Rx only
300 mg (15 mL when mixed)
Amneal Pharmaceuticals LLC

1
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300 mg carton
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NDC 65162-758-83
Azithromycin for oral suspension USP, 200 mg/5 mL
Rx only
600 mg (15 mL when mixed)
Amneal Pharmaceuticals LLC

2
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600 mg carton
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NDC 65162-759-39
Azithromycin for oral suspension USP, 200 mg/5 mL
Rx only
900 mg (22.5 mL when mixed) Amneal Pharmaceuticals LLC

3
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900 mg carton
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NDC 65162-760-84
Azithromycin for oral suspension USP, 200 mg/5 mL
Rx only
1200 mg (30 mL when mixed) Amneal Pharmaceuticals LLC

4
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1200 mg carton
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AZITHROMYCIN MONOHYDRATE azithromycin monohydrate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-708
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SUCROSE
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA, VANILLA (creme de vanilla) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-708-83 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (65162-708-83)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205666 07/23/2018
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-758
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SUCROSE
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA, VANILLA (creme de vanilla) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-758-83 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (65162-758-83)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205666 07/23/2018
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-759
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SUCROSE
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA, VANILLA (creme de vanilla) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-759-39 1 BOTTLE in 1 CARTON contains a BOTTLE
1 22.5 mL in 1 BOTTLE This package is contained within the CARTON (65162-759-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205666 07/23/2018
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-760
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SUCROSE
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA, VANILLA (creme de vanilla) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-760-84 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (65162-760-84)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205666 07/23/2018
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 analysis (65162-708), analysis (65162-758), analysis (65162-759), analysis (65162-760), label (65162-708), label (65162-758), label (65162-759), label (65162-760), manufacture (65162-708), manufacture (65162-758), manufacture (65162-759), manufacture (65162-760), pack (65162-708), pack (65162-758), pack (65162-759), pack (65162-760)

Revised: 02/2022 Amneal Pharmaceuticals LLC

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