NDC 35356-909-30
API & Excipient Details

Oxybutynin Hydrochloride marketed by Lake Erie Medical DBA Quality Care Products LLC under NDC Code 35356-909-30

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBUTYNIN CHLORIDE(UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)	OXYBUTYNIN CHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35356-909-30	30 in 1 BOTTLE
2	NDC:35356-909-60	60 in 1 BOTTLE
3	NDC:35356-909-90	90 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076745	05/11/2007

PRINCIPAL DISPLAY PANEL