NDC 70518-1063

Glipizide

Glipizide

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

Product ID70518-1063_6857d8ec-1c7d-4c4a-e053-2991aa0a13ce
NDC70518-1063
Product TypeHuman Prescription Drug
Proprietary NameGlipizide
Generic NameGlipizide
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-03-13
Marketing CategoryANDA / ANDA
Application NumberANDA204720
Labeler NameREMEDYREPACK INC.
Substance NameGLIPIZIDE
Active Ingredient Strength5 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1063-0

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-1063-0)
Marketing Start Date2018-03-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1063-0 [70518106300]

Glipizide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204720
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-13

NDC 70518-1063-1 [70518106301]

Glipizide TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204720
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-21

Drug Details

Active Ingredients

IngredientStrength
GLIPIZIDE5 mg/1

OpenFDA Data

SPL SET ID:c2aadc88-22d2-467c-b2cb-03efb5a1f1c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314006
  • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

    NDC Crossover Matching brand name "Glipizide" 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
    68071-1773GlipizideGlipizide
    68071-3009GlipizideGlipizide
    68071-3141GlipizideGlipizide
    68071-4223GlipizideGlipizide
    68071-4124GlipizideGlipizide
    68071-4085GlipizideGlipizide
    68071-4378GlipizideGlipizide
    68071-4498GlipizideGlipizide
    68071-4020GlipizideGlipizide
    68071-4232GlipizideGlipizide
    68071-4643GlipizideGlipizide
    68382-337GlipizideGlipizide
    68382-336GlipizideGlipizide
    68382-335GlipizideGlipizide
    68645-575GlipizideGlipizide
    68788-0141GlipizideGlipizide
    68645-151GlipizideGlipizide
    68645-574GlipizideGlipizide
    68788-0142GlipizideGlipizide
    68788-7250GlipizideGlipizide
    68788-6853GlipizideGlipizide
    68788-6854GlipizideGlipizide
    68788-9176GlipizideGlipizide
    68788-7230GlipizideGlipizide
    68788-9918GlipizideGlipizide
    70518-0029GlipizideGlipizide
    70518-0104GlipizideGlipizide
    70518-0552GlipizideGlipizide
    70518-0115GlipizideGlipizide
    70518-0389GlipizideGlipizide
    70518-0358GlipizideGlipizide
    70518-1124GlipizideGlipizide
    70518-0998GlipizideGlipizide
    70518-1063GlipizideGlipizide
    70518-0574GlipizideGlipizide

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