NDC Code(s) : 43386-471-61, 43386-470-60
Packager : Lupin Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AzithromycinAzithromycin FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-471
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
TRIBASIC SODIUM PHOSPHATE(UNII: A752Q30A6X)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color WHITE (Off-White) Score
Shape Size
Flavor CHERRY, VANILLA, BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43386-471-611 in 1 CARTON 27/09/2017
130 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065488 09/27/2017
AzithromycinAzithromycin FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-470
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
TRIBASIC SODIUM PHOSPHATE(UNII: A752Q30A6X)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color WHITE (Off-White) Score
Shape Size
Flavor CHERRY, VANILLA, BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43386-470-601 in 1 CARTON 27/09/2017
115 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065488 09/27/2017

LABELER - Lupin Pharmaceuticals,Inc.(089153071)

REGISTRANT - Novel Laboratories, Inc.(793518643)

Establishment
Name Address ID/FEI Business Operations
Novel Laboratories, Inc. 793518643 MANUFACTURE(43386-470, 43386-471), ANALYSIS(43386-470, 43386-471)

PRINCIPAL DISPLAY PANEL

Azithromycin for Oral Suspension, 100 mg/5 mL

Container Label

NDC:  43386-470-60

300 mg

Carton Label

300 mg

Azithromycin for Oral Suspension, 200 mg/5 mL

1200 mg- Container Label

NDC 43386-471-61

300 mg

Carton Label

300 mg