Nitroglycerin

Product NDC
0404-9928
11-digit product format
004049928
Labeler code
0404
Product ID
0404-9928_4d6839d6-a200-4bb6-ba39-6c52bb6a371f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA072034
Marketing category
ANDA
Marketing start
2022-01-13
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
0404-9928-10Nitroglycerin10 mL in 1 VIALINJECTION, SOLUTION106
0404-9928-10Nitroglycerin1 in 1 BAGINJECTION, SOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9928NITROGLYCERIN INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20241212_578d8159-5ec6-457f-b4a8-9add624d43a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9928-10004049928101 VIAL in 1 BAG (0404-9928-10) / 10 mL in 1 VIAL1 vial2022-01-130000-00-00NoNoCurrent