NDC Code(s) : 35356-909-30, 35356-909-60, 35356-909-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-909(NDC:0093-5207)
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
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
METHACRYLIC ACID(UNII: 1CS02G8656)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color PINK (light pink) Score no score
Shape ROUND (film-coated, round, convex) Size 7 mm
Flavor Imprint Code G342
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-909-3030 in 1 BOTTLE
2NDC:35356-909-6060 in 1 BOTTLE
3NDC:35356-909-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076745 05/11/2007

PRINCIPAL DISPLAY PANEL

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