DailyMed - GLIPIZIDE tablet, extended release

NDC Code(s): 70771-1098-0, 70771-1098-1, 70771-1098-2, 70771-1098-3, view more
70771-1098-4, 70771-1098-5, 70771-1098-6, 70771-1098-9, 70771-1099-0, 70771-1099-1, 70771-1099-2, 70771-1099-3, 70771-1099-4, 70771-1099-5, 70771-1099-6, 70771-1099-9, 70771-1100-0, 70771-1100-1, 70771-1100-2, 70771-1100-3, 70771-1100-4, 70771-1100-5, 70771-1100-6, 70771-1100-9
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 13, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1098-3 in bottle of 30 tablets

Glipizide Tablets, 2.5 mg

Rx only

30 tablets

ZYDUS

NDC 70771-1099-3 in bottle of 30 tablets

Glipizide Tablets, 5 mg

Rx only

30 tablets

ZYDUS

NDC 70771-1100-3 in bottle of 30 tablets

Glipizide Tablets, 10 mg

Rx only

30 tablets

ZYDUS

INGREDIENTS AND APPEARANCE

GLIPIZIDE
glipizide tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1098
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)	GLIPIZIDE	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
ALUMINUM OXIDE (UNII: LMI26O6933)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (Yellow)	Score	no score
Shape	ROUND (Round)	Size	6mm
Flavor		Imprint Code	2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1098-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
2	NDC:70771-1098-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
3	NDC:70771-1098-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
4	NDC:70771-1098-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
5	NDC:70771-1098-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
6	NDC:70771-1098-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
7	NDC:70771-1098-4	10 in 1 CARTON	07/25/2018
7	NDC:70771-1098-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203499	07/25/2018

GLIPIZIDE
glipizide tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1099
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Orange)	Score	no score
Shape	ROUND (Round)	Size	6mm
Flavor		Imprint Code	3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1099-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
2	NDC:70771-1099-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
3	NDC:70771-1099-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
4	NDC:70771-1099-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
5	NDC:70771-1099-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
6	NDC:70771-1099-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
7	NDC:70771-1099-4	10 in 1 CARTON	07/25/2018
7	NDC:70771-1099-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203499	07/25/2018

GLIPIZIDE
glipizide tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1100
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (White)	Score	no score
Shape	ROUND (Round)	Size	6mm
Flavor		Imprint Code	4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1100-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
2	NDC:70771-1100-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
3	NDC:70771-1100-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
4	NDC:70771-1100-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
5	NDC:70771-1100-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
6	NDC:70771-1100-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2018
7	NDC:70771-1100-4	10 in 1 CARTON	07/25/2018
7	NDC:70771-1100-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203499	07/25/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1098, 70771-1099, 70771-1100) , MANUFACTURE(70771-1098, 70771-1099, 70771-1100)

View All Sections

Published Date (What is this?)	Version	Files
Oct 18, 2022	5 (current)	download
Dec 7, 2020	4	download
Dec 3, 2019	3	download
Aug 21, 2018	2	download
Jul 25, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	310489	glipiZIDE 2.5 MG 24HR Extended Release Oral Tablet	PSN
2	310489	24 HR glipizide 2.5 MG Extended Release Oral Tablet	SCD
3	310489	glipizide ER 2.5 MG 24 HR Extended Release Oral Tablet	SY
4	310489	glipizide XL 2.5 MG 24 HR Extended Release Oral Tablet	SY
5	314006	glipiZIDE 5 MG 24HR Extended Release Oral Tablet	PSN
6	314006	24 HR glipizide 5 MG Extended Release Oral Tablet	SCD
7	314006	glipizide ER 5 MG 24 HR Extended Release Oral Tablet	SY
8	314006	glipizide XL 5 MG 24 HR Extended Release Oral Tablet	SY
9	315107	glipiZIDE 10 MG 24HR Extended Release Oral Tablet	PSN
10	315107	24 HR glipizide 10 MG Extended Release Oral Tablet	SCD
11	315107	glipizide ER 10 MG 24 HR Extended Release Oral Tablet	SY
12	315107	glipizide XL 10 MG 24 HR Extended Release Oral Tablet	SY

Label: GLIPIZIDE tablet, extended release

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	70771-1098-0
2	70771-1098-1
3	70771-1098-2
4	70771-1098-3
5	70771-1098-4
6	70771-1098-5
7	70771-1098-6
8	70771-1098-9
9	70771-1099-0
10	70771-1099-1
11	70771-1099-2
12	70771-1099-3
13	70771-1099-4
14	70771-1099-5
15	70771-1099-6
16	70771-1099-9
17	70771-1100-0
18	70771-1100-1
19	70771-1100-2
20	70771-1100-3
21	70771-1100-4
22	70771-1100-5
23	70771-1100-6
24	70771-1100-9

Label: GLIPIZIDE tablet, extended release

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

GLIPIZIDE tablet, extended release

Number of versions: 5

GLIPIZIDE tablet, extended release

GLIPIZIDE tablet, extended release

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

GLIPIZIDE tablet, extended release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.