NDC Code(s) : 55695-002-00, 55695-003-00, 55695-003-01
Packager : STATE HEALTH SERVICES, TEXAS DEPARTMENT OF

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AzithromycinAzithromycin 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(UNII: JTE4MNN1MD)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA, VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55695-002-0015 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065246 12/28/2010
AzithromycinAzithromycin 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(UNII: JTE4MNN1MD)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA, VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55695-003-0030 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2010
2NDC:55695-003-0115 mL in 1 BOTTLE Type 0: Not a Combination Product28/12/2010
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)

PRINCIPAL DISPLAY PANEL

55695-002

PRINCIPAL DISPLAY PANEL

55695-003