FDA.reportPublic FDA data

Nitroglycerin

Product NDC
66993-241
11-digit product format
669930241
Labeler code
66993
Product ID
66993-241_59e636f9-55b0-4474-8227-307f6e9023c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
SPRAY
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA018705
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-12-02
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
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
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
66993-241-41Nitroglycerin200 in 1 BOTTLE, SPRAYSPRAY2002
66993-241-41Nitroglycerin1 in 1 CARTONSPRAY12
66993-241-50Nitroglycerin1 in 1 CARTONSPRAY12
66993-241-50Nitroglycerin60 in 1 BOTTLE, SPRAYSPRAY602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-241-41GM - Gram66993-24143707cf4-ae5a-4a49-8d30-6fa470ab87ef12024-12-10
66993-241-50GM - Gram66993-2419a7cb951-b4a3-4392-b937-9cf20cc56c0e12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-241NITROGLYCERIN SPRAY [PRASCO LABORATORIES]1Current NDC, 4 package rows20241203_f9731c86-34b0-42a2-8b39-eca907e02e74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSNf9731c86-34b0-42a2-8b39-eca907e02e742
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCDf9731c86-34b0-42a2-8b39-eca907e02e742
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySYf9731c86-34b0-42a2-8b39-eca907e02e742
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySYf9731c86-34b0-42a2-8b39-eca907e02e742
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySYf9731c86-34b0-42a2-8b39-eca907e02e742
705129NTG 0.4 MG/ACTUAT Mucosal SpraySYf9731c86-34b0-42a2-8b39-eca907e02e742
705129TNG 0.4 MG/ACTUAT Mucosal SpraySYf9731c86-34b0-42a2-8b39-eca907e02e742
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN422b4713-9531-f1bf-e063-6294a90ada2b1
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD422b4713-9531-f1bf-e063-6294a90ada2b1
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY422b4713-9531-f1bf-e063-6294a90ada2b1
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY422b4713-9531-f1bf-e063-6294a90ada2b1
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY422b4713-9531-f1bf-e063-6294a90ada2b1
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY422b4713-9531-f1bf-e063-6294a90ada2b1
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY422b4713-9531-f1bf-e063-6294a90ada2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66993-241-41669930241411 BOTTLE, SPRAY in 1 CARTON (66993-241-41) / 200 SPRAY in 1 BOTTLE, SPRAY2024-12-02NoNoCurrent
66993-241-50669930241501 BOTTLE, SPRAY in 1 CARTON (66993-241-50) / 60 SPRAY in 1 BOTTLE, SPRAY2024-12-02NoNoCurrent