NDC 70007-300

NITROLINGUAL

Nitroglycerin

NITROLINGUAL is a Oral Spray in the Human Prescription Drug category. It is labeled and distributed by Espero Pharmaceuticals, Inc.. The primary component is Nitroglycerin.

• Product ID: 70007-300_806a9c83-efeb-4862-acec-0fc43839e23d
• NDC: 70007-300
• Product Type: Human Prescription Drug
• Proprietary Name: NITROLINGUAL
• Generic Name: Nitroglycerin
• Dosage Form: Spray
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA018705
• 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 70007-300-20

1 BOTTLE, SPRAY in 1 CARTON (70007-300-20) > 200 SPRAY in 1 BOTTLE, SPRAY

• Marketing Start Date: 2016-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70007-300-65 [70007030065]

NITROLINGUAL SPRAY

• Marketing Category: NDA
• Application Number: NDA018705
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-03-01
• Inactivation Date: 2020-01-31

NDC 70007-300-20 [70007030020]

NITROLINGUAL SPRAY

• Marketing Category: NDA
• Application Number: NDA018705
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-03-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NITROGLYCERIN	400 ug/1

OpenFDA Data

• SPL SET ID: 2b7c772a-adef-4eef-bb83-aaa798e1b712
• Manufacturer:
  • Espero Pharmaceuticals, Inc.
• UNII:
  • G59M7S0WS3
• RxNorm Concept Unique ID - RxCUI:
  • 995019
  • 705129

Pharmacological Class

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

Medicade Reported Pricing

70007030065 NITROLINGUAL 0.4 MG SPRAY

Pricing Unit: GM | Drug Type:

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

NDC	Brand Name	Generic Name
70007-300	NITROLINGUAL	NITROLINGUAL
28595-550	NITROLINGUAL	NITROLINGUAL
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