NDC 50742-516

NITRO-DUR

Nitroglycerin

NITRO-DUR is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Nitroglycerin.

Product ID50742-516_09b44e68-4676-43fd-a975-a9822f1eec76
NDC50742-516
Product TypeHuman Prescription Drug
Proprietary NameNITRO-DUR
Generic NameNitroglycerin
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2017-12-06
Marketing CategoryNDA / NDA
Application NumberNDA020145
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameNITROGLYCERIN
Active Ingredient Strength80 mg/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50742-516-30

30 POUCH in 1 BOX, UNIT-DOSE (50742-516-30) > 1 PATCH in 1 POUCH
Marketing Start Date2017-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-516-30 [50742051630]

NITRO-DUR PATCH
Marketing CategoryNDA
Application NumberNDA020145
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-06

Drug Details

Active Ingredients

IngredientStrength
NITROGLYCERIN80 mg/1

OpenFDA Data

SPL SET ID:5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861657
  • 486148
  • 899607
  • 486146
  • 486152
  • 899521
  • 899642
  • 899705
  • 899703
  • 899690
  • 899660
  • 899688
  • Pharmacological Class

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

    NDC Crossover Matching brand name "NITRO-DUR" or generic name "Nitroglycerin"

    NDCBrand NameGeneric Name
    50742-514NITRO-DURNITRO-DUR
    50742-518NITRO-DURNITRO-DUR
    50742-515NITRO-DURNITRO-DUR
    50742-516NITRO-DURNITRO-DUR
    50742-513NITRO-DURNITRO-DUR
    50742-517NITRO-DURNITRO-DUR
    0220-2279GlonoinumNITROGLYCERIN
    0220-2282GlonoinumNITROGLYCERIN
    0220-2283GlonoinumNITROGLYCERIN
    0220-2286GlonoinumNITROGLYCERIN
    0220-2287GlonoinumNITROGLYCERIN
    0220-2290GlonoinumNITROGLYCERIN
    0220-2291GlonoinumNITROGLYCERIN
    0220-2293GlonoinumNITROGLYCERIN
    0168-0326NITRO-BIDNitroglycerin
    0281-0326NITRO-BIDNitroglycerin
    0904-0643Nitro-TimeNitroglycerin
    0904-0644Nitro-TimeNitroglycerin
    0904-0647Nitro-TimeNitroglycerin
    0378-9102Nitroglycerinnitroglycerin
    0378-9104Nitroglycerinnitroglycerin
    0378-9112Nitroglycerinnitroglycerin
    0378-9116Nitroglycerinnitroglycerin
    0404-9928NitroglycerinNitroglycerin
    0517-4810Nitroglycerinnitroglycerin
    0338-1047Nitroglycerin In DextroseNitroglycerin
    0338-1049Nitroglycerin In DextroseNitroglycerin
    0338-1051Nitroglycerin In DextroseNitroglycerin
    0904-5495Nitroglycerin Transdermal Systemnitroglycerin
    0071-0417Nitrostatnitroglycerin
    0071-0418Nitrostatnitroglycerin
    0071-0419Nitrostatnitroglycerin
    0404-9929NITROSTATnitroglycerin

    Trademark Results [NITRO-DUR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NITRO-DUR
    NITRO-DUR
    73255779 1245737 Live/Registered
    Key Pharmaceutical, Inc.
    1980-03-28

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