NDC 70934-391

Glipizide XL

Glipizide

Glipizide XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The primary component is Glipizide.

Product ID70934-391_8aa9095e-b53d-c5b7-e053-2995a90aa6b9
NDC70934-391
Product TypeHuman Prescription Drug
Proprietary NameGlipizide XL
Generic NameGlipizide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-06-05
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020329
Labeler NameDenton Pharma, Inc. DBA Northwind Pharmaceuticals
Substance NameGLIPIZIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70934-391-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-391-30)
Marketing Start Date2020-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70934-391-30 [70934039130]

Glipizide XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA020329
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-27

NDC 70934-391-90 [70934039190]

Glipizide XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA020329
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-05

Drug Details

Active Ingredients

IngredientStrength
GLIPIZIDE10 mg/1

OpenFDA Data

SPL SET ID:8aa8ee11-19fd-82a1-e053-2995a90ad7b0
Manufacturer
UNII

Pharmacological Class

  • Sulfonylurea [EPC]
  • Sulfonylurea Compounds [CS]

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

NDCBrand NameGeneric Name
53808-0408Glipizide XLGlipizide XL
53808-0409Glipizide XLGlipizide XL
53808-0942Glipizide XLGlipizide XL
55154-0539Glipizide XLGlipizide XL
59762-0542Glipizide XLGlipizide XL
59762-0540Glipizide XLGlipizide XL
59762-0541Glipizide XLGlipizide XL
70934-391Glipizide XLGlipizide XL
51655-361Glipizide XLGlipizide XL
0378-1105Glipizideglipizide
0378-1110Glipizideglipizide
0591-0460GlipizideGlipizide
0591-0461GlipizideGlipizide
0591-0844GlipizideGlipizide
0591-0845GlipizideGlipizide
0591-0900GlipizideGlipizide
0615-3595GlipizideGlipizide
0615-3596GlipizideGlipizide
0615-5584GlipizideGlipizide
0615-5585GlipizideGlipizide
0615-6596GlipizideGlipizide
0615-7968GlipizideGlipizide
0615-7969GlipizideGlipizide
0615-8407GlipizideGlipizide
0049-0170Glucotrolglipizide
0049-0174Glucotrolglipizide
0049-0178Glucotrolglipizide
0049-4110Glucotrolglipizide
0049-4120Glucotrolglipizide

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.