FDA.reportPublic FDA data

nitroglycerin lingual

Product NDC
45802-210
11-digit product format
458020210
Labeler code
45802
Product ID
45802-210_e75425f2-a532-4b73-9b24-258a7dcc34b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
SPRAY
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA091496
Marketing category
ANDA
Marketing start
2013-09-20
Substance
NITROGLYCERIN
Active strength
400 ug/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nitroglycerin lingual
Listing expiration
2026-12-31

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
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-210-01nitroglycerin lingual1 in 1 CARTONSPRAY18
45802-210-01nitroglycerin lingual60 in 1 BOTTLESPRAY608
45802-210-02nitroglycerin lingual1 in 1 CARTONSPRAY18
45802-210-02nitroglycerin lingual200 in 1 BOTTLESPRAY2008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-210-01GM - Gram45802-210cab59bf7-7a7d-4f2e-8353-d44e0b5ffbdb12013-10-17
45802-210-02GM - Gram45802-210feebf190-6c0f-4213-b3fa-c5e4aeca611312013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PERRIGO NEW YORK INC]3
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PERRIGO NEW YORK INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PERRIGO NEW YORK INC]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UNITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PERRIGO NEW YORK INC]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-210NITROGLYCERIN LINGUAL (NITROGLYCERIN) SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 4 package rows20231025_e7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSNe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCDe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129NTG 0.4 MG/ACTUAT Mucosal SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129TNG 0.4 MG/ACTUAT Mucosal SpraySYe7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d8
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY9483ea48-0b1e-68c0-e053-2995a90a84d53
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY947e4e68-ef8a-6c63-e053-2a95a90ac1933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-210-01458020210011 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLE1 bottle2013-09-200000-00-00NoNoCurrent
45802-210-02458020210021 BOTTLE in 1 CARTON (45802-210-02) / 200 SPRAY in 1 BOTTLE1 bottle2013-09-200000-00-00NoNoCurrent