NDC Code(s) : 53002-2231-2, 53002-2231-1
Packager : RPK Pharmaceuticals, Inc.

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:53002-2231(NDC:42806-151)
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
BANANA(UNII: 4AJZ4765R9)
CHERRY(UNII: BUC5I9595W)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
Product Characteristics
Color WHITE (Off-white), pink Score
Shape Size
Flavor BANANA, CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53002-2231-230 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2020
2NDC:53002-2231-115 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207531 04/10/2018

LABELER - RPK Pharmaceuticals, Inc.(147096275)

Establishment
Name Address ID/FEI Business Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL(53002-2231)

PRINCIPAL DISPLAY PANEL

Label Image