NDC 28595-705

GONITRO

Nitroglycerin

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

• Product ID: 28595-705_7e58f2e8-89a3-4e86-b436-3999740cba16
• NDC: 28595-705
• Product Type: Human Prescription Drug
• Proprietary Name: GONITRO
• Generic Name: Nitroglycerin
• Dosage Form: Powder
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2019-07-01
• Marketing End Date: 2023-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA208424
• Labeler Name: Allegis Pharmaceuticals, Inc.
• Substance Name: NITROGLYCERIN
• Active Ingredient Strength: 400 ug/1
• Pharm Classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
• NDC Exclude Flag: N

Packaging

NDC 28595-705-12

12 PACKET in 1 BOX (28595-705-12) > 1 POWDER in 1 PACKET (28595-705-01)

• Marketing Start Date: 2019-07-01
• Marketing End Date: 2023-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 28595-705-96 [28595070596]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 28595-705-01 [28595070501]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 28595-705-99 [28595070599]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 28595-705-36 [28595070536]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 28595-705-12 [28595070512]

GONITRO POWDER

• Marketing Category: NDA
• Application Number: NDA208424
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

Drug Details

Active Ingredients

Ingredient	Strength
NITROGLYCERIN	400 ug/1

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