NDC 28595-550

NITROLINGUAL

Nitroglycerin

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

Product ID28595-550_b137fec5-9f0a-43b2-b532-583cc72dc636
NDC28595-550
Product TypeHuman Prescription Drug
Proprietary NameNITROLINGUAL
Generic NameNitroglycerin
Dosage FormSpray
Route of AdministrationORAL
Marketing Start Date2019-07-01
Marketing CategoryNDA / NDA
Application NumberNDA018705
Labeler NameAllegis Pharmaceuticals, LLC
Substance NameNITROGLYCERIN
Active Ingredient Strength400 ug/1
Pharm ClassesNitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 28595-550-12

1 BOTTLE, SPRAY in 1 CARTON (28595-550-12) > 200 SPRAY in 1 BOTTLE, SPRAY
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28595-550-49 [28595055049]

NITROLINGUAL SPRAY
Marketing CategoryNDA
Application NumberNDA018705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

NDC 28595-550-12 [28595055012]

NITROLINGUAL SPRAY
Marketing CategoryNDA
Application NumberNDA018705
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
NITROGLYCERIN400 ug/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
70007-300NITROLINGUALNITROLINGUAL
28595-550NITROLINGUALNITROLINGUAL
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 [NITROLINGUAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NITROLINGUAL
NITROLINGUAL
73062058 1035175 Live/Registered
BOSKAMP, ARTHUR
1975-09-04
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.