NDC Code(s) : 50090-0369-1, 50090-0369-3
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IsoniazidIsoniazid TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0369(NDC:0527-1109)
Route of Administration ORAL, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISONIAZID(UNII: V83O1VOZ8L)
(ISONIAZID - UNII:V83O1VOZ8L) 		ISONIAZID300 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE(UNII: 4846Q921YM)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
CALCIUM STEARATE(UNII: 776XM7047L)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code LAN;1109
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0369-1 100 in 1 BOTTLE Type 0: Not a Combination Product29/06/2016
2NDC:50090-0369-3 30 in 1 BOTTLE Type 0: Not a Combination Product29/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089776 10/10/2013 03/31/2017

PRINCIPAL DISPLAY PANEL

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