NDC Code(s) : 61786-516-02, 61786-516-19
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MethocarbamolMethocarbamol TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-516(NDC:31722-534)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOCARBAMOL(UNII: 125OD7737X)
(METHOCARBAMOL - UNII:125OD7737X) 		METHOCARBAMOL750 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
POVIDONE K90(UNII: RDH86HJV5Z)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white (White to Offwhite) Score no score
Shape OVAL (Capsule shaped) Size 19 mm
Flavor Imprint Code 115;H
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-516-0230 in 1 BLISTER PACK Type 0: Not a Combination Product29/12/2015
2NDC:61786-516-1990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090200 12/29/2015

PRINCIPAL DISPLAY PANEL

DRUG: Methocarbamol

GENERIC: Methocarbamol

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-516-02

NDC: 61786-516-19

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 19 mm

IMPRINT: 115;H

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • METHOCARBAMOL 750mg in 1

INACTIVE INGREDIENT(S):

  • HYDROXYPROPYL CELLULOSE
  • SILICON DIOXIDE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • POVIDONE K90
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • SODIUM LAURYL SULFATE
  • STEARIC ACID

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/xml/00701ec8-7f8c-4132-8204-da93bffb5a59/Remedy_Label.jpg