Azithromycin Monohydrate (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azithromycin Tablets USP, 500 mg

43063715 Label
(click image for full-size original)
AZITHROMYCIN MONOHYDRATE azithromycin monohydrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-715(NDC:68180-161)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CROSCARMELLOSE SODIUM
D&C RED NO. 30
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color pink Score no score
Shape OVAL Size 17mm
Flavor Imprint Code LU;L12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-715-02 2 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065399 08/18/2015
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-715)

Revised: 04/2022 PD-Rx Pharmaceuticals, Inc.

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