NDC Code(s) : 10370-190-01, 10370-190-05, 10370-191-01, 10370-191-05
Packager : Par Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10370-190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE(UNII: X7WDT95N5C)
(GLIPIZIDE - UNII:X7WDT95N5C) 		GLIPIZIDE5 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code WPI;844
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10370-190-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/02/2015
2NDC:10370-190-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076467 07/02/2015 01/31/2019
Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10370-191
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE(UNII: X7WDT95N5C)
(GLIPIZIDE - UNII:X7WDT95N5C) 		GLIPIZIDE10 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SHELLAC(UNII: 46N107B71O)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color WHITE (to off-white) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code WPI;845
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10370-191-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/02/2015
2NDC:10370-191-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076467 07/02/2015 01/31/2019

PRINCIPAL DISPLAY PANEL

5 mg

PRINCIPAL DISPLAY PANEL

10 mg