FDA.reportPublic FDA data

Nitroglycerin In Dextrose

Product NDC
0338-1051
11-digit product format
003381051
Labeler code
0338
Product ID
0338-1051_b89cb9ff-d275-465b-b70b-d8e2e9406435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
NDA019970
Marketing category
NDA
Marketing start
1989-12-29
Substance
NITROGLYCERIN
Active strength
40 mg/100mL
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitroglycerin In Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN40 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui312004, 1868494, 1868562

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
0338-1051-022022-12-09C16284748780-1e4f33bdf-ae99-d8a0-e053-dadaa90a6e4eNitroglycerin in 5% Dextrose Injection For intravenous use only
0338-1051-022022-07-29C16284748780-1e4f33bdf-ae99-d8a0-e053-dadaa90a6e4eNitroglycerin in 5% Dextrose Injection For intravenous use only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-1051-02Nitroglycerin In Dextrose250 mL in 1 BOTTLE, GLASSINJECTION25014
0338-1051-02Nitroglycerin In Dextrose12 in 1 BOXINJECTION1214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1051-02ML - Milliliter0338-10513060597f-f10b-4190-aa40-fd891b5758c212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GNITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RNITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1051NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]13Current NDC, Legacy NDC, 2 package rows20250514_457a026c-ebce-4701-9deb-2d7652759a99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1868494nitroglycerin 100 MG in 250 ML InjectionPSN457a026c-ebce-4701-9deb-2d7652759a9914
1868562nitroglycerin 25 MG in 250 ML InjectionPSN457a026c-ebce-4701-9deb-2d7652759a9914
312004nitroglycerin 50 MG in 250 ML InjectionPSN457a026c-ebce-4701-9deb-2d7652759a9914
1868562250 ML nitroglycerin 0.1 MG/ML InjectionSCD457a026c-ebce-4701-9deb-2d7652759a9914
312004250 ML nitroglycerin 0.2 MG/ML InjectionSCD457a026c-ebce-4701-9deb-2d7652759a9914
1868494250 ML nitroglycerin 0.4 MG/ML InjectionSCD457a026c-ebce-4701-9deb-2d7652759a9914
1868562250 ML NTG 0.1 MG/ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
312004250 ML NTG 0.2 MG/ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
1868494250 ML NTG 0.4 MG/ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
1868562250 ML TNG 0.1 MG/ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
312004250 ML TNG 0.2 MG/ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
1868494250 ML TNG 0.4 MG/ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
1868494nitroglycerin 100 MG per 250 ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
312004nitroglycerin 200 MCG/ML per 250 ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914
1868562nitroglycerin 25 MG per 250 ML InjectionSY457a026c-ebce-4701-9deb-2d7652759a9914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0338-1051-020033810510212 BOTTLE, GLASS in 1 BOX (0338-1051-02) / 250 mL in 1 BOTTLE, GLASS1989-12-290000-00-00NoNoCurrent