NDC 33261-835

GlipizideER ER

Glipizide

GlipizideER ER is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Glipizide.

Product ID33261-835_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad
NDC33261-835
Product TypeHuman Prescription Drug
Proprietary NameGlipizideER ER
Generic NameGlipizide
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2003-11-07
Marketing CategoryANDA / ANDA
Application NumberANDA076467
Labeler NameAidarex Pharmaceuticals LLC
Substance NameGLIPIZIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33261-835-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-835-30)
Marketing Start Date2003-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-835-30 [33261083530]

GlipizideER ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076467
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-11-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GLIPIZIDE10 mg/1

OpenFDA Data

SPL SET ID:6c92a536-508d-4e94-89af-453e3eb2a560
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314006
  • 315107
  • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

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

    NDCBrand NameGeneric Name
    33261-835GlipizideER ERGlipizideER ER
    33261-830GlipizideER ERGlipizideER ER
    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

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