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 ID: 50742-516_09b44e68-4676-43fd-a975-a9822f1eec76
• NDC: 50742-516
• Product Type: Human Prescription Drug
• Proprietary Name: NITRO-DUR
• Generic Name: Nitroglycerin
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2017-12-06
• Marketing Category: NDA / NDA
• Application Number: NDA020145
• Labeler Name: Ingenus Pharmaceuticals, LLC
• Substance Name: NITROGLYCERIN
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50742-516-30

30 POUCH in 1 BOX, UNIT-DOSE (50742-516-30) > 1 PATCH in 1 POUCH

• Marketing Start Date: 2017-12-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50742-516-30 [50742051630]

NITRO-DUR PATCH

• Marketing Category: NDA
• Application Number: NDA020145
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-06

Drug Details

Active Ingredients

Ingredient	Strength
NITROGLYCERIN	80 mg/1

OpenFDA Data

• SPL SET ID: 5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0
• Manufacturer:
  • Ingenus Pharmaceuticals, LLC
• UNII:
  • G59M7S0WS3
• 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"

NDC	Brand Name	Generic Name
50742-514	NITRO-DUR	NITRO-DUR
50742-518	NITRO-DUR	NITRO-DUR
50742-515	NITRO-DUR	NITRO-DUR
50742-516	NITRO-DUR	NITRO-DUR
50742-513	NITRO-DUR	NITRO-DUR
50742-517	NITRO-DUR	NITRO-DUR
0220-2279	Glonoinum	NITROGLYCERIN
0220-2282	Glonoinum	NITROGLYCERIN
0220-2283	Glonoinum	NITROGLYCERIN
0220-2286	Glonoinum	NITROGLYCERIN
0220-2287	Glonoinum	NITROGLYCERIN
0220-2290	Glonoinum	NITROGLYCERIN
0220-2291	Glonoinum	NITROGLYCERIN
0220-2293	Glonoinum	NITROGLYCERIN
0168-0326	NITRO-BID	Nitroglycerin
0281-0326	NITRO-BID	Nitroglycerin
0904-0643	Nitro-Time	Nitroglycerin
0904-0644	Nitro-Time	Nitroglycerin
0904-0647	Nitro-Time	Nitroglycerin
0378-9102	Nitroglycerin	nitroglycerin
0378-9104	Nitroglycerin	nitroglycerin
0378-9112	Nitroglycerin	nitroglycerin
0378-9116	Nitroglycerin	nitroglycerin
0404-9928	Nitroglycerin	Nitroglycerin
0517-4810	Nitroglycerin	nitroglycerin
0338-1047	Nitroglycerin In Dextrose	Nitroglycerin
0338-1049	Nitroglycerin In Dextrose	Nitroglycerin
0338-1051	Nitroglycerin In Dextrose	Nitroglycerin
0904-5495	Nitroglycerin Transdermal System	nitroglycerin
0071-0417	Nitrostat	nitroglycerin
0071-0418	Nitrostat	nitroglycerin
0071-0419	Nitrostat	nitroglycerin
0404-9929	NITROSTAT	nitroglycerin