NITROLINGUAL
These highlights do not include all the information needed to use NITROLINGUAL® PUMPSPRAY safely and effectively. See full prescribing information for NITROLINGUAL PUMPSPRAY. NITROLINGUAL® PUMPSPRAY (nitroglycerin) lingual spray Initial U.S. Approval: 1997
Approved
Approval ID
d8765f0e-1fe9-4e2a-9138-186c093edceb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Allegis Pharmaceuticals, LLC
DUNS: 792272861
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code28595-550
Application NumberNDA018705
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (6)
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
NITROGLYCERINActive
Quantity: 400 ug in 1 1
Code: G59M7S0WS3
Classification: ACTIB