FDA.reportPublic FDA data

Dobutamine Hydrochloride in Dextrose

Product NDC
0338-1077
11-digit product format
003381077
Labeler code
0338
Product ID
0338-1077_34c787c1-46f7-4264-951d-c88a34dca533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dobutamine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA020255
Marketing category
NDA
Marketing start
1993-09-23
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
400 mg/100mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dobutamine Hydrochloride in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOBUTAMINE HYDROCHLORIDE400 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WR771DJXV
Rxcui309985, 309986, 309987

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c061d745-4e41-be68-87e9-bad2cb726830Product name220240208
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
020518de-5dfd-f3a9-9c93-8015dad30497Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-1077-02Dobutamine Hydrochloride in Dextrose18 in 1 CARTONINJECTION1823
0338-1077-02Dobutamine Hydrochloride in Dextrose250 mL in 1 BAGINJECTION25023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1077-02ML - Milliliter0338-10772b8a7cd3-264a-4d82-b83d-efa9347ecf7212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOBUTAMINE HYDROCHLORIDEACTIVE INGREDIENT0WR771DJXVDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8
DOBUTAMINEACTIVE MOIETY3S12J47372DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8
WATERINACTIVE INGREDIENT059QF0KO0RDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1077DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]22Current NDC, Legacy NDC, 2 package rows20250315_6b17b98b-e06d-42ed-925f-69aa2699dead.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309987DOBUTamine 1000 MG in 250 ML InjectionPSN6b17b98b-e06d-42ed-925f-69aa2699dead23
309985DOBUTamine 250 MG in 250 ML InjectionPSN6b17b98b-e06d-42ed-925f-69aa2699dead23
309986DOBUTamine 500 MG in 250 ML InjectionPSN6b17b98b-e06d-42ed-925f-69aa2699dead23
309985250 ML dobutamine 1 MG/ML InjectionSCD6b17b98b-e06d-42ed-925f-69aa2699dead23
309986250 ML dobutamine 2 MG/ML InjectionSCD6b17b98b-e06d-42ed-925f-69aa2699dead23
309987250 ML dobutamine 4 MG/ML InjectionSCD6b17b98b-e06d-42ed-925f-69aa2699dead23
309987dobutamine (as dobutamine HCl) 1000 MG per 250 ML InjectionSY6b17b98b-e06d-42ed-925f-69aa2699dead23
309985dobutamine (as dobutamine HCl) 250 MG per 250 ML InjectionSY6b17b98b-e06d-42ed-925f-69aa2699dead23
309986dobutamine (as dobutamine HCl) 500 MG per 250 ML InjectionSY6b17b98b-e06d-42ed-925f-69aa2699dead23
309987dobutamine 1000 MG per 250 ML InjectionSY6b17b98b-e06d-42ed-925f-69aa2699dead23
309985dobutamine 250 MG per 250 ML InjectionSY6b17b98b-e06d-42ed-925f-69aa2699dead23
309986dobutamine 500 MG per 250 ML InjectionSY6b17b98b-e06d-42ed-925f-69aa2699dead23
309987DOBUTamine 1000 MG in 250 ML InjectionPSN7f56a751-5769-4622-9008-e7fef8e543625
309987250 ML dobutamine 4 MG/ML InjectionSCD7f56a751-5769-4622-9008-e7fef8e543625
309987dobutamine (as dobutamine HCl) 1000 MG per 250 ML InjectionSY7f56a751-5769-4622-9008-e7fef8e543625
309987dobutamine 1000 MG per 250 ML InjectionSY7f56a751-5769-4622-9008-e7fef8e543625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1077-020033810770218 BAG in 1 CARTON (0338-1077-02) / 250 mL in 1 BAG18 bag1993-09-270000-00-00NoNoCurrent