NDC 0049-0178

Glucotrol XL

Glipizide

Glucotrol XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Glipizide.

• Product ID: 0049-0178_60be542a-179a-42f1-bc4b-ee13cfde5e64
• NDC: 0049-0178
• Product Type: Human Prescription Drug
• Proprietary Name: Glucotrol XL
• Generic Name: Glipizide
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-05-09
• Marketing Category: NDA / NDA
• Application Number: NDA020329
• Labeler Name: Roerig
• Substance Name: GLIPIZIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0049-0178-07

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-07)

• Marketing Start Date: 2013-05-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0049-0178-07 [00049017807]

Glucotrol XL TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020329
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-09

NDC 0049-0178-08 [00049017808]

Glucotrol XL TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020329
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-09

Drug Details

Active Ingredients

Ingredient	Strength
GLIPIZIDE	10 mg/1

OpenFDA Data

• SPL SET ID: eed99b60-d043-4249-9b2a-f05e46fb588d
• Manufacturer:
  • Roerig
• UNII:
  • X7WDT95N5C
• RxNorm Concept Unique ID - RxCUI:
  • 865568
  • 315107
  • 865573
  • 865571
  • 310489
  • 314006
• UPC Code:
  • 0300490178075
  • 0300490170017

Pharmacological Class

• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]
• Sulfonylurea [EPC]
• Sulfonylurea Compounds [CS]

NDC Crossover Matching brand name "Glucotrol XL" or generic name "Glipizide"

NDC	Brand Name	Generic Name
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