NDC 0049-0170

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 ID0049-0170_60be542a-179a-42f1-bc4b-ee13cfde5e64
NDC0049-0170
Product TypeHuman Prescription Drug
Proprietary NameGlucotrol XL
Generic NameGlipizide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-07-15
Marketing CategoryNDA / NDA
Application NumberNDA020329
Labeler NameRoerig
Substance NameGLIPIZIDE
Active Ingredient Strength3 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0049-0170-01

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0170-01)
Marketing Start Date2013-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0049-0170-01 [00049017001]

Glucotrol XL TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020329
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-15

Drug Details

Active Ingredients

IngredientStrength
GLIPIZIDE2.5 mg/1

OpenFDA Data

SPL SET ID:eed99b60-d043-4249-9b2a-f05e46fb588d
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    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

    Trademark Results [Glucotrol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLUCOTROL
    GLUCOTROL
    77283409 not registered Dead/Abandoned
    Eurotrol B.V.
    2007-09-19
    GLUCOTROL
    GLUCOTROL
    73174918 1111601 Live/Registered
    PFIZER INC.
    1978-06-19

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