NDC Code(s) : 61786-928-02
Packager : REMEDYREPACK INC.

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:61786-928(NDC:10135-584)
Route of Administration 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 K29/32(UNII: 390RMW2PEQ)
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:61786-928-0230 in 1 BLISTER PACK Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089776 10/12/2016

PRINCIPAL DISPLAY PANEL

DRUG: Isoniazid

GENERIC: Isoniazid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-928-02

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: LAN;1109

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ISONIAZID 300mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM STEARATE
  • POVIDONE K29/32
  • CALCIUM SULFATE DIHYDRATE
  • CROSCARMELLOSE SODIUM
  • STARCH, CORN

/xml/0d6be0bf-a451-4cea-ae19-b3869759c59a/Remedy_Label.jpg