NDC Code(s) : 49349-406-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methotrexate SodiumMethotrexate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-406
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE SODIUM(UNII: 3IG1E710ZN)
(METHOTREXATE - UNII:YL5FZ2Y5U1) 		METHOTREXATE2.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code B;572
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-406-0230 in 1 BLISTER PACK Type 0: Not a Combination Product27/05/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081099 05/27/2010 01/13/2012

PRINCIPAL DISPLAY PANEL

DRUG: Methotrexate

GENERIC: Methotrexate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-406-02

COLOR: yellow

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: b;572

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • METHOTREXATE SODIUM 2.5mg in 1

INACTIVE INGREDIENT(S):

  • HYPROMELLOSES
  • PROPYLENE GLYCOL
  • SODIUM CARBONATE MONOHYDRATE
  • STARCH, CORN
  • POLYETHYLENE GLYCOLS
  • ANHYDROUS LACTOSE
  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • TALC

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