NDC Code(s) : 21695-548-15, 21695-549-15, 21695-549-22, 21695-549-30
Packager : Rebel Distributors Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AzithromycinAzithromycin monohydrate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-548(NDC:0093-7148)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
azithromycin monohydrate(UNII: JTE4MNN1MD)
(azithromycin - UNII:F94OW58Y8V) 		azithromycin monohydrate100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ethyl vanillin(UNII: YC9ST449YJ)
hydroxypropyl cellulose(UNII: RFW2ET671P)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
sucrose(UNII: C151H8M554)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(UNII: B70850QPHR)
vanillin(UNII: CHI530446X)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:21695-548-1515 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065419 06/24/2008
AzithromycinAzithromycin monohydrate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-549(NDC:0093-7149)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
azithromycin monohydrate(UNII: JTE4MNN1MD)
(azithromycin - UNII:F94OW58Y8V) 		azithromycin monohydrate200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
XANTHAN GUM(UNII: TTV12P4NEE)
ethyl vanillin(UNII: YC9ST449YJ)
hydroxypropyl cellulose(UNII: RFW2ET671P)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
sucrose(UNII: C151H8M554)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(UNII: B70850QPHR)
vanillin(UNII: CHI530446X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:21695-549-1515 mL in 1 BOTTLE
2NDC:21695-549-2222.5 mL in 1 BOTTLE
3NDC:21695-549-3030 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065419 06/24/2008

LABELER - Rebel Distributors Corp.(118802834)

Establishment
Name Address ID/FEI Business Operations
Rebel Distributors Corp. 118802834 RELABEL, REPACK

PRINCIPAL DISPLAY PANEL

Azithromycin 100mg/5ml Label

PRINCIPAL DISPLAY PANEL

Azithromycin 200mg/5ml Label