NDC Code(s) : 52125-706-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxybutynin ChlorideExtended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-706(NDC:62175-271)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN CHLORIDE(UNII: L9F3D9RENQ)
(OXYBUTYNIN - UNII:K9P6MC7092) 		OXYBUTYNIN CHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TARTARIC ACID(UNII: W4888I119H)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white Score no score
Shape ROUND (TABLET, EXTENDED RELEASE) Size 8 mm
Flavor Imprint Code KU;271
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-706-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078503 09/19/2013 09/19/2014

PRINCIPAL DISPLAY PANEL

DRUG: Oxybutynin ChlorideExtended Release Extended Release


GENERIC: Oxybutynin Chloride


DOSAGE: TABLET, EXTENDED RELEASE


ADMINSTRATION: ORAL


NDC: 52125-706-02


ACTIVE INGREDIENT(S):

  • OXYBUTYNIN CHLORIDE 10mg in 1


INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • POLYETHYLENE GLYCOL 400
  • TITANIUM DIOXIDE
  • CELLULOSE ACETATE
  • FERROSOFERRIC OXIDE
  • HYPROMELLOSE 2208 (100 MPA.S)
  • PROPYLENE GLYCOL
  • ANHYDROUS DEXTROSE
  • LACTOSE MONOHYDRATE
  • MANNITOL
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
  • TARTARIC ACID
  • TRIACETIN


COLOR: white


SHAPE: ROUND


SCORE: No score


SIZE: 8 mm


IMPRINT: KU;271


PACKAGING: 30 in 1 BLISTER PACK



/xml/09d13a0c-e3b8-408d-8c5c-8b0275b6a353/MM8.jpg

/xml/09d13a0c-e3b8-408d-8c5c-8b0275b6a353/MM8.jpg