NDC 0591-0844

Glipizide ER

Glipizide

Glipizide ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Glipizide.

• Product ID: 0591-0844_15a7fd91-5bf6-4d7d-959a-5de13a43d0ea
• NDC: 0591-0844
• Product Type: Human Prescription Drug
• Proprietary Name: Glipizide ER
• Generic Name: Glipizide
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2003-11-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076467
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: GLIPIZIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0591-0844-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-0844-01)

• Marketing Start Date: 2003-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-0844-10 [00591084410]

Glipizide ER TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076467
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-11-19

NDC 0591-0844-15 [00591084415]

Glipizide ER TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076467
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-11-19
• Marketing End Date: 2017-08-31

NDC 0591-0844-30 [00591084430]

Glipizide ER TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076467
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-11-19
• Marketing End Date: 2011-04-03

NDC 0591-0844-01 [00591084401]

Glipizide ER TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076467
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-11-19

Drug Details

Active Ingredients

Ingredient	Strength
GLIPIZIDE	5 mg/1

OpenFDA Data

• SPL SET ID: a430577c-f233-40a7-bfd8-3d2bc6f98aa2
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • X7WDT95N5C
• RxNorm Concept Unique ID - RxCUI:
  • 310489
  • 314006
  • 315107

Pharmacological Class

• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]

NDC Crossover Matching brand name "Glipizide ER" or generic name "Glipizide"

NDC	Brand Name	Generic Name
68071-1557	Glipizide ER	Glipizide ER
68071-2181	Glipizide ER	Glipizide ER
68071-1944	Glipizide ER	Glipizide ER
68071-4010	Glipizide ER	Glipizide ER
68071-4133	Glipizide ER	Glipizide ER
68084-112	Glipizide ER	Glipizide ER
68084-111	Glipizide ER	Glipizide ER
68084-295	Glipizide ER	Glipizide ER
68151-0765	Glipizide ER	Glipizide ER
70518-0827	Glipizide ER	Glipizide ER
70518-0288	Glipizide ER	Glipizide ER
70518-0456	Glipizide ER	Glipizide ER
21695-967	Glipizide ER	Glipizide ER
50090-2222	Glipizide ER	Glipizide ER
50436-6302	Glipizide ER	Glipizide ER
50436-0908	Glipizide ER	Glipizide ER
53808-0401	Glipizide ER	Glipizide ER
55289-301	Glipizide ER	Glipizide ER
55289-779	Glipizide ER	Glipizide ER
61919-725	GLIPIZIDE ER	GLIPIZIDE ER
63629-5256	Glipizide ER	Glipizide ER
63629-3158	Glipizide ER	Glipizide ER
63629-7093	Glipizide ER	Glipizide ER
63629-4071	Glipizide ER	Glipizide ER
66336-269	Glipizide ER	Glipizide ER
61919-850	GLIPIZIDE ER	GLIPIZIDE ER
70518-2579	Glipizide ER	Glipizide ER
70518-2549	Glipizide ER	Glipizide ER
50090-0852	Glipizide ER	Glipizide ER
72189-070	GLIPIZIDE ER	GLIPIZIDE ER
0378-1105	Glipizide	glipizide
0378-1110	Glipizide	glipizide
0591-0460	Glipizide	Glipizide
0591-0461	Glipizide	Glipizide
0591-0844	Glipizide	Glipizide
0591-0845	Glipizide	Glipizide
0591-0900	Glipizide	Glipizide
0615-3595	Glipizide	Glipizide
0615-3596	Glipizide	Glipizide
0615-5584	Glipizide	Glipizide
0615-5585	Glipizide	Glipizide
0615-6596	Glipizide	Glipizide
0615-7968	Glipizide	Glipizide
0615-7969	Glipizide	Glipizide
0615-8407	Glipizide	Glipizide
0049-0170	Glucotrol	glipizide
0049-0174	Glucotrol	glipizide
0049-0178	Glucotrol	glipizide
0049-4110	Glucotrol	glipizide
0049-4120	Glucotrol	glipizide