Glipizideer tablet, film coated, extended release

Ingredients and appearance - Product information

Glipizideer tablet, film coated, extended release- Glipizide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 10370-190
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Glipizide ( UNII: X7WDT95N5C)( Glipizide - UNII: X7WDT95N5C ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Acetyltributyl citrate ( UNII: 0ZBX0N59RZ)
Hydroxyethyl cellulose (2000 cps at 1%) ( UNII: S38J6RZN16)
Hydroxypropyl cellulose (1600000 wamw) ( UNII: RFW2ET671P)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Methacrylic acid - methyl methacrylate copolymer (1:1) ( UNII: 74G4R6TH13)
Polyethylene glycol, unspecified ( 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 Imprint Code WPI;844
Score 1 Shape ROUND
Size 6 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 10370-190-01 100 in 1 BOTTLE, PLASTIC 2015/07/02
2 NDC: 10370-190-05 500 in 1 BOTTLE, PLASTIC 2015/07/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076467 USA 2015/07/02

Glipizideer tablet, film coated, extended release- Glipizide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 10370-191
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Glipizide ( UNII: X7WDT95N5C)( Glipizide - UNII: X7WDT95N5C ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Acetyltributyl citrate ( UNII: 0ZBX0N59RZ)
Hydroxyethyl cellulose (2000 cps at 1%) ( UNII: S38J6RZN16)
Hydroxypropyl cellulose (1600000 wamw) ( UNII: RFW2ET671P)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Methacrylic acid - methyl methacrylate copolymer (1:1) ( UNII: 74G4R6TH13)
Polyethylene glycol, unspecified ( 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) Imprint Code WPI;845
Score 1 Shape ROUND
Size 6 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 10370-191-01 100 in 1 BOTTLE, PLASTIC 2015/07/02
2 NDC: 10370-191-05 500 in 1 BOTTLE, PLASTIC 2015/07/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076467 USA 2015/07/02

Labeler - Par Pharmaceuticals, Inc.( 092733690)