NDC Code(s) : 69189-0758-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PiroxicamPiroxicam CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0758(NDC:0093-0756)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIROXICAM(UNII: 13T4O6VMAM)
(PIROXICAM - UNII:13T4O6VMAM) 		PIROXICAM10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
GELATIN(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K30(UNII: U725QWY32X)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYLENE GLYCOL MONOETHYL ETHER(UNII: IDK7C2HS09)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
DIMETHICONE(UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color GREEN (dark green), GREEN (olive) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0758-11 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074131 11/10/2015

PRINCIPAL DISPLAY PANEL

Piroxicam 10 mg capsule label