NDC Code(s) : 49349-393-02
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:49349-393
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISONIAZID(UNII: V83O1VOZ8L)
(ISONIAZID - UNII:V83O1VOZ8L) 		ISONIAZID100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POVIDONE K29/32(UNII: 390RMW2PEQ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code E;4354
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-393-0230 in 1 BLISTER PACK Type 0: Not a Combination Product01/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA008678 09/01/2016 09/01/2016

PRINCIPAL DISPLAY PANEL

DRUG: Isoniazid

GENERIC: Isoniazid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-393-02

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: E;4354;

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ISONIAZID 100mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • STARCH, CORN
  • SILICON DIOXIDE
  • POVIDONE K29/32
  • STEARIC ACID

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