NDC 68382-309

Nitroglycerin Transdermal System

Nitroglycerin Transdermal System

Nitroglycerin Transdermal System is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Nitroglycerin.

Product ID68382-309_1445184a-35fb-4ba3-bdb4-38a8c4fd1455
NDC68382-309
Product TypeHuman Prescription Drug
Proprietary NameNitroglycerin Transdermal System
Generic NameNitroglycerin Transdermal System
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA089884
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameNITROGLYCERIN
Active Ingredient Strength0 mg/h
Pharm ClassesNitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-309-30

30 POUCH in 1 CARTON (68382-309-30) > 1 PATCH in 1 POUCH (68382-309-01) > 14 h in 1 PATCH
Marketing Start Date2017-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-309-01 [68382030901]

Nitroglycerin Transdermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089884
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-15

NDC 68382-309-30 [68382030930]

Nitroglycerin Transdermal System PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089884
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-15

Drug Details

Active Ingredients

IngredientStrength
NITROGLYCERIN.2 mg/h

OpenFDA Data

SPL SET ID:e3da9f52-d094-49d2-90d8-994bd839a4a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486146
  • 486152
  • 486148
    • UPC Code
  • 0368382309303
  • 0368382310309

    • Pharmacological Class

    • Nitrate Vasodilator [EPC]
    • Nitrates [CS]
    • Vasodilation [PE]

    Medicade Reported Pricing

    68382030930 NITROGLYCERIN 0.2 MG/HR PATCH

    Pricing Unit: EA | Drug Type:

    68382030901 NITROGLYCERIN 0.2 MG/HR PATCH

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Nitroglycerin Transdermal System" or generic name "Nitroglycerin Transdermal System"

    NDCBrand NameGeneric Name
    0904-5495Nitroglycerin Transdermal Systemnitroglycerin
    0904-5496Nitroglycerin Transdermal Systemnitroglycerin
    0904-5497Nitroglycerin Transdermal SystemNitroglycerin
    49730-111Nitroglycerin Transdermal SystemNitroglycerin
    49730-112Nitroglycerin Transdermal SystemNitroglycerin
    49730-113Nitroglycerin Transdermal SystemNitroglycerin
    68382-309Nitroglycerin Transdermal SystemNitroglycerin Transdermal System
    68382-310Nitroglycerin Transdermal SystemNitroglycerin Transdermal System
    68382-311Nitroglycerin Transdermal SystemNitroglycerin Transdermal System
    70710-1477Nitroglycerin Transdermal SystemNitroglycerin Transdermal System
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.