Azithromycin (Page 9 of 9)

Package Labeling (55695-002-00)

55695-002
(click image for full-size original)

Package Labeling (55695-003-00)

55695-003
(click image for full-size original)

AZITHROMYCIN
azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-002(NDC:0093-2027)
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
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
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 Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55695-002-00 15 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065246 12/28/2010
AZITHROMYCIN
azithromycin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-003(NDC:0093-2026)
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
DIMETHYLAMINOETHYL METHACRYLATE — BUTYL METHACRYLATE — METHYL METHACRYLATE COPOLYMER
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 Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55695-003-00 30 mL in 1 BOTTLE None
2 NDC:55695-003-01 15 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065246 12/17/2010
Labeler — STATE HEALTH SERVICES, TEXAS DEPARTMENT OF (781992540)

Revised: 01/2022 STATE HEALTH SERVICES, TEXAS DEPARTMENT OF

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