GLUCOTROL XL- glipizide tablet, extended release

Glucotrol by

Drug Labeling and Warnings

Glucotrol by is a Prescription medication manufactured, distributed, or labeled by Roerig, Pfizer Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - Shipping Label - 10 mg

GLUCOTROL XL 10 MG TABLETS
(GLIPIZIDE GITS) BULK INTERNATIONAL

PRODUCT CODE: H000127184 (07781–990)

LOT NUMBER: XXXXXXXXXX

MANUFACTURE (API ADDED DATE) : XXXXXXXXXXXXXX

CONTENTS:

GROSS WEIGHT: _______________KG

TARE WEIGHT: ________________KG

NET WEIGHT: _________________KG

DRUM NUMBER:

NO. OF TABLETS:

STORAGE: STORE AT CONTROLLED ROOM TEMPERATURE,
59 °F TO 86 °F (15 °C TO 30 °C) PROTECT FROM MOISTURE
AND HUMIDITY MADE IN USA - FOR EXPORT ONLY

Rx only
CAUTION: For Manufacturing, Processing or Repacking.

Pfizer
Pfizer Pharmaceuticals LLC
Barceloneta, PR 00617

06-1399-00-5

PRINCIPAL DISPLAY PANEL - Shipping Label - 5 mg

GLUCOTROL XL 5 MG PRINTED TABLETS COATED
(GLIPIZIDE GITS) BULK INTERNATIONAL

PRODUCT CODE: H000127182 (07785–990)

LOT NUMBER: XXXXXXXXXX

MANUFACTURE (API ADDED DATE) : XXXXXXXXXXXXXX

CONTENTS:

GROSS WEIGHT: _______________KG

TARE WEIGHT: ________________KG

NET WEIGHT: _________________KG

DRUM NUMBER:

NO. OF TABLETS:

STORAGE: STORE AT CONTROLLED ROOM TEMPERATURE,
59 °F TO 86 °F (15 °C TO 30 °C) PROTECT FROM MOISTURE
AND HUMIDITY MADE IN USA - FOR EXPORT ONLY

Rx only
CAUTION: For Manufacturing, Processing or Repacking.

Pfizer
Pfizer Pharmaceuticals LLC
Barceloneta, PR 00617

06-1399-00-5

INGREDIENTS AND APPEARANCE

GLUCOTROL   XL
glipizide tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0049-1582
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)	GLIPIZIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (biconvex)	Size	10mm
Flavor		Imprint Code	GLX;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0049-1582-01	150000 in 1 DRUM; Type 0: Not a Combination Product	05/09/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		05/09/2013

GLUCOTROL   XL
glipizide tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0049-1581
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)	GLIPIZIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (biconvex)	Size	8mm
Flavor		Imprint Code	GXL;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0049-1581-01	150000 in 1 DRUM; Type 0: Not a Combination Product	05/09/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		05/09/2013

Labeler - Roerig (829076996)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Pharmaceuticals LLC		829084545	ANALYSIS(0049-1581, 0049-1582) , API MANUFACTURE(0049-1581, 0049-1582) , MANUFACTURE(0049-1581, 0049-1582) , PACK(0049-1581, 0049-1582)

Establishment
Name	Address	ID/FEI	Business Operations
Pfizer Pharmaceuticals LLC		829084552	PACK(0049-1581, 0049-1582)