Azithromycin Dihydrate (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 250 mg Tablet Carton

NDC 71205-430-061 Cartons × 6 Tablets

Azithromycin Tablets, USP

250 mg

A full course of antibiotic therapy in 5 daily doses

Rx only

71205-430-06
(click image for full-size original)
AZITHROMYCIN DIHYDRATE azithromycin dihydrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-430(NDC:51224-022)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azithromycin Dihydrate (Azithromycin anhydrous) Azithromycin anhydrous 250 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 1
Lecithin, soybean
FD&C RED NO. 40
FD&C YELLOW NO. 6
polyethylene glycol 3350
magnesium stearate
polyvinyl alcohol, unspecified
STARCH, CORN
talc
titanium dioxide
Product Characteristics
Color RED Score no score
Shape OVAL Size 13mm
Flavor Imprint Code OE;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-430-04 4 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:71205-430-06 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (71205-430-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208250 07/01/2019
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-430), RELABEL (71205-430)

Revised: 05/2022 Proficient Rx LP

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