NDC 70007-400

GONITRO

Nitroglycerin

GONITRO is a Sublingual Powder in the Human Prescription Drug category. It is labeled and distributed by Espero Pharmaceuticals, Inc.. The primary component is Nitroglycerin.

• Product ID: 70007-400_677e8d16-0bd2-4cc5-8d23-98e9cc0cf676
• NDC: 70007-400
• Product Type: Human Prescription Drug
• Proprietary Name: GONITRO
• Generic Name: Nitroglycerin
• Dosage Form: Powder
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2016-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA208424
• Labeler Name: Espero Pharmaceuticals, Inc.
• Substance Name: NITROGLYCERIN
• Active Ingredient Strength: 400 ug/1
• Pharm Classes: Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70007-400-12

12 PACKET in 1 BOX (70007-400-12) > 1 POWDER in 1 PACKET (70007-400-01)

• Marketing Start Date: 2016-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70007-400-99 [70007040099]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-01
• Inactivation Date: 2020-01-31

NDC 70007-400-36 [70007040036]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-01
• Inactivation Date: 2020-01-31

NDC 70007-400-12 [70007040012]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-01
• Inactivation Date: 2020-01-31

NDC 70007-400-96 [70007040096]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-01
• Inactivation Date: 2020-01-31

NDC 70007-400-01 [70007040001]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-01

Drug Details

Active Ingredients

Ingredient	Strength
NITROGLYCERIN	400 ug/1

OpenFDA Data

• SPL SET ID: 1418d832-4a6a-45ab-8414-25e23f393abb
• Manufacturer:
  • Espero Pharmaceuticals, Inc.
• UNII:
  • G59M7S0WS3
• RxNorm Concept Unique ID - RxCUI:
  • 1799434
  • 1799428
• UPC Code:
  • 1011213400968

Pharmacological Class

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

NDC Crossover Matching brand name "GONITRO" or generic name "Nitroglycerin"

NDC	Brand Name	Generic Name
70007-400	GONITRO	GONITRO
28595-705	GONITRO	GONITRO
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