Azithromycin

AZITHROMYCIN- azithromycin dihydrate powder, for suspension
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1422-1

Azithromycin for oral suspension, 300 mg

100 mg/5 mL

Rx only

Azithromycin oral suspension
(click image for full-size original)

NDC 70771-1423-2

Azithromycin for oral suspension, 600 mg

200 mg/5 mL

Rx only

Azithromycin oral suspension
(click image for full-size original)

NDC 70771-1424-2

Azithromycin for oral suspension, 900 mg

200 mg/5 mL

Rx only

Azithromycin oral suspension
(click image for full-size original)

NDC 70771-1425-2

Azithromycin for oral suspension, 1200 mg

200 mg/5 mL

Rx only

Azithromycin oral suspension
(click image for full-size original)
AZITHROMYCIN
azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1422
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (90000 WAMW)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SUCROSE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO LIGHT PINK) Score
Shape Size
Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1422-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (70771-1422-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211147 08/06/2018
AZITHROMYCIN
azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1423
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (90000 WAMW)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SUCROSE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO LIGHT PINK) Score
Shape Size
Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1423-2 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (70771-1423-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211147 08/06/2018
AZITHROMYCIN
azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1424
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (90000 WAMW)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SUCROSE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO LIGHT PINK) Score
Shape Size
Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1424-2 1 BOTTLE in 1 CARTON contains a BOTTLE
1 22.5 mL in 1 BOTTLE This package is contained within the CARTON (70771-1424-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211147 08/06/2018
AZITHROMYCIN
azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1425
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (90000 WAMW)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
SUCROSE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO LIGHT PINK) Score
Shape Size
Flavor CHERRY (CHERRY) , BANANA (RIPE BANANA) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1425-2 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (70771-1425-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211147 08/06/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — CADILA HEALTHCARE LIMITED (677605858)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (70771-1422), ANALYSIS (70771-1423), ANALYSIS (70771-1424), ANALYSIS (70771-1425), MANUFACTURE (70771-1422), MANUFACTURE (70771-1423), MANUFACTURE (70771-1424), MANUFACTURE (70771-1425)

Revised: 08/2020 Cadila Healthcare Limited

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