FDA.reportPublic FDA data

NITROGLYCERIN IN DEXTROSE

Product NDC
51662-1332
11-digit product format
516621332
Labeler code
51662
Product ID
51662-1332_ef6d3bae-5390-440c-e053-2995a90a3a9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN, DEXTROSE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA019970
Marketing category
NDA
Marketing start
2018-11-26
Substance
NITROGLYCERIN
Active strength
20 mg/100mL
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 IN DEXTROSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN20 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui312004

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
00358076-c817-430b-b924-11d717dc307cProduct name120160718
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1332-12020-02-07C16284748780-19d75b9d0-a984-f424-e053-dadaa90a57ceNITROGLYCERIN IN 5% DEXTROSE INJECTION 50mg PER 250mL VIAL
51662-1332-12020-01-31C16284748780-19d75b9d0-a984-f424-e053-dadaa90a57ceNITROGLYCERIN IN 5% DEXTROSE INJECTION 50mg PER 250mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1332-1NITROGLYCERIN IN DEXTROSE250 mL in 1 BOTTLE, GLASSINJECTION2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1332NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN, DEXTROSE) INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 1 package rows20221211_7b98d1fc-44b2-08a1-e053-2991aa0af3ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312004nitroglycerin 50 MG in 250 ML InjectionPSN7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004250 ML nitroglycerin 0.2 MG/ML InjectionSCD7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004250 ML NTG 0.2 MG/ML InjectionSY7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004250 ML TNG 0.2 MG/ML InjectionSY7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004nitroglycerin 200 MCG/ML per 250 ML InjectionSY7b98d1fc-44b2-08a1-e053-2991aa0af3ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1332-151662133201250 mL in 1 BOTTLE, GLASS (51662-1332-1) 250 ml2018-11-260000-00-00NoNoCurrent