FDA.reportPublic FDA data

NITROGLYCERIN LINGUAL

Product NDC
28595-120
11-digit product format
285950120
Labeler code
28595
Product ID
28595-120_462b36d0-0a1e-bda8-e063-6294a90a5792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
SPRAY
Route
ORAL
Labeler
Allegis Pharmaceuticals, LLC
Application
NDA018705
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-07-01
Marketing end
2027-01-31
Substance
NITROGLYCERIN
Active strength
400 ug/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITROGLYCERIN LINGUAL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN400 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui705129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
00358076-c817-430b-b924-11d717dc307cProduct name120160718
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-120-12NITROGLYCERIN LINGUAL1 in 1 CARTONSPRAY13
28595-120-12NITROGLYCERIN LINGUAL200 in 1 BOTTLESPRAY2003
28595-120-49NITROGLYCERIN LINGUAL1 in 1 CARTONSPRAY13
28595-120-49NITROGLYCERIN LINGUAL60 in 1 BOTTLESPRAY603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-120-12GM - Gram28595-1209ec2d2f6-83f5-4e07-9a9a-a1874e367b8a12020-09-14
28595-120-49GM - Gram28595-120dd50fdf6-d069-497a-8022-a506c184635e12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-120NITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [ALLEGIS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 4 package rows20230202_fadd07b7-189b-4678-ad0f-bf1e4d3d1300.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSNa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCDa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySYa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySYa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySYa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129NTG 0.4 MG/ACTUAT Mucosal SpraySYa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129TNG 0.4 MG/ACTUAT Mucosal SpraySYa8eb91f6-7f2e-7d57-e053-2995a90a38935
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSNfadd07b7-189b-4678-ad0f-bf1e4d3d13003
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCDfadd07b7-189b-4678-ad0f-bf1e4d3d13003
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySYfadd07b7-189b-4678-ad0f-bf1e4d3d13003
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySYfadd07b7-189b-4678-ad0f-bf1e4d3d13003
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySYfadd07b7-189b-4678-ad0f-bf1e4d3d13003
705129NTG 0.4 MG/ACTUAT Mucosal SpraySYfadd07b7-189b-4678-ad0f-bf1e4d3d13003
705129TNG 0.4 MG/ACTUAT Mucosal SpraySYfadd07b7-189b-4678-ad0f-bf1e4d3d13003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28595-120-12285950120121 BOTTLE in 1 CARTON (28595-120-12) / 200 SPRAY in 1 BOTTLE1 bottle2019-07-012026-05-31NoNoCurrent
28595-120-49285950120491 BOTTLE in 1 CARTON (28595-120-49) / 60 SPRAY in 1 BOTTLE1 bottle2019-07-012027-01-31NoNoCurrent