Nitroglycerin

Product NDC
0517-4810
11-digit product format
005174810
Labeler code
0517
Product ID
0517-4810_ee83c8b9-c31a-4f32-9e9d-0370545204cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA072034
Marketing category
ANDA
Marketing start
2003-03-04
Substance
NITROGLYCERIN
Active strength
5 mg/mL
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
NITROGLYCERIN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui237205

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
0517-4810-01Nitroglycerin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION107
0517-4810-25Nitroglycerin25 in 1 TRAYINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-4810-01ML - Milliliter0517-4810416f8942-e0d3-49e4-9e3d-3e6c37affe1912026-03-17
0517-4810-25ML - Milliliter0517-4810d0d0b1d8-5d26-4f89-a790-deb2ff2199a812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
nitroglycerinACTIVE MOIETYG59M7S0WS3NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MNITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RNITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-4810NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]7Current NDC, Legacy NDC, 2 package rows20210723_8c52cdf6-87be-4719-b105-f08be096d462.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237205nitroglycerin 50 MG in 10 ML InjectionPSN8c52cdf6-87be-4719-b105-f08be096d4627
23720510 ML nitroglycerin 5 MG/ML InjectionSCD8c52cdf6-87be-4719-b105-f08be096d4627
23720510 ML NTG 5 MG/ML InjectionSY8c52cdf6-87be-4719-b105-f08be096d4627
23720510 ML TNG 5 MG/ML InjectionSY8c52cdf6-87be-4719-b105-f08be096d4627
237205nitroglycerin 50 MG per 10 ML InjectionSY8c52cdf6-87be-4719-b105-f08be096d4627
237205nitroglycerin 50 MG in 10 ML InjectionPSN578d8159-5ec6-457f-b4a8-9add624d43a86
23720510 ML nitroglycerin 5 MG/ML InjectionSCD578d8159-5ec6-457f-b4a8-9add624d43a86
23720510 ML NTG 5 MG/ML InjectionSY578d8159-5ec6-457f-b4a8-9add624d43a86
23720510 ML TNG 5 MG/ML InjectionSY578d8159-5ec6-457f-b4a8-9add624d43a86
237205nitroglycerin 50 MG per 10 ML InjectionSY578d8159-5ec6-457f-b4a8-9add624d43a86
237205nitroglycerin 50 MG in 10 ML InjectionPSN9453bd8b-5d54-5dc8-e053-2995a90a95b25
23720510 ML nitroglycerin 5 MG/ML InjectionSCD9453bd8b-5d54-5dc8-e053-2995a90a95b25
23720510 ML NTG 5 MG/ML InjectionSY9453bd8b-5d54-5dc8-e053-2995a90a95b25
23720510 ML TNG 5 MG/ML InjectionSY9453bd8b-5d54-5dc8-e053-2995a90a95b25
237205nitroglycerin 50 MG per 10 ML InjectionSY9453bd8b-5d54-5dc8-e053-2995a90a95b25
237205nitroglycerin 50 MG in 10 ML InjectionPSNb8af0974-33ea-4dd5-9ff7-3b61272aeb252
23720510 ML nitroglycerin 5 MG/ML InjectionSCDb8af0974-33ea-4dd5-9ff7-3b61272aeb252
23720510 ML NTG 5 MG/ML InjectionSYb8af0974-33ea-4dd5-9ff7-3b61272aeb252
23720510 ML TNG 5 MG/ML InjectionSYb8af0974-33ea-4dd5-9ff7-3b61272aeb252
237205nitroglycerin 50 MG per 10 ML InjectionSYb8af0974-33ea-4dd5-9ff7-3b61272aeb252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-4810-010051748100110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0517-4810-250051748102525 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01) 2003-03-040000-00-00NoNoCurrent