Nitroglycerin

Product NDC
70518-4232
11-digit product format
705184232
Labeler code
70518
Product ID
70518-4232_40062900-8718-646e-e063-6394a90a9e33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA072034
Marketing category
ANDA
Marketing start
2024-11-14
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
70518-4232-0Nitroglycerin25 in 1 TRAYINJECTION, SOLUTION252
70518-4232-1Nitroglycerin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4232NITROGLYCERIN INJECTION, SOLUTION [REMEDYREPACK INC.]1Current NDC, 2 package rows20241121_b8af0974-33ea-4dd5-9ff7-3b61272aeb25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
70518-4232-07051842320025 VIAL, SINGLE-DOSE in 1 TRAY (70518-4232-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4232-1) 2024-11-14NoNoCurrent
70518-4232-17051842320110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical