FDA.reportPublic FDA data

Dobutamine in Dextrose

Product NDC
0409-3724
11-digit product format
004093724
Labeler code
0409
Product ID
0409-3724_1c7cc97c-e244-4a4b-a4a1-8b70ca812107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dobutamine in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA020201
Marketing category
NDA
Marketing start
2005-10-12
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

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
0409-3724-11Dobutamine in Dextrose250 mL in 1 BAGINJECTION, SOLUTION25027
0409-3724-32Dobutamine in Dextrose12 in 1 CASEINJECTION, SOLUTION1227
0409-3724-32Dobutamine in Dextrose1 in 1 POUCHINJECTION, SOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3724-32ML - Milliliter0409-37245bf3f9cb-6192-49c4-b2ae-a00d308f364d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOBUTAMINE HYDROCHLORIDEACTIVE INGREDIENT0WR771DJXVDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
DOBUTAMINEACTIVE MOIETY3S12J47372DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RDOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]11
DOBUTAMINE HYDROCHLORIDEACTIVE INGREDIENT0WR771DJXVDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
DOBUTAMINEACTIVE MOIETY3S12J47372DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3724DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.]26Current NDC, Legacy NDC, 3 package rows20241211_9943a961-3b50-4847-8a84-d8414ce38daa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309987DOBUTamine 1000 MG in 250 ML InjectionPSN9943a961-3b50-4847-8a84-d8414ce38daa27
309985DOBUTamine 250 MG in 250 ML InjectionPSN9943a961-3b50-4847-8a84-d8414ce38daa27
309986DOBUTamine 500 MG in 250 ML InjectionPSN9943a961-3b50-4847-8a84-d8414ce38daa27
309985250 ML dobutamine 1 MG/ML InjectionSCD9943a961-3b50-4847-8a84-d8414ce38daa27
309986250 ML dobutamine 2 MG/ML InjectionSCD9943a961-3b50-4847-8a84-d8414ce38daa27
309987250 ML dobutamine 4 MG/ML InjectionSCD9943a961-3b50-4847-8a84-d8414ce38daa27
309987dobutamine (as dobutamine HCl) 1000 MG per 250 ML InjectionSY9943a961-3b50-4847-8a84-d8414ce38daa27
309985dobutamine (as dobutamine HCl) 250 MG per 250 ML InjectionSY9943a961-3b50-4847-8a84-d8414ce38daa27
309986dobutamine (as dobutamine HCl) 500 MG per 250 ML InjectionSY9943a961-3b50-4847-8a84-d8414ce38daa27
309987dobutamine 1000 MG per 250 ML InjectionSY9943a961-3b50-4847-8a84-d8414ce38daa27
309985dobutamine 250 MG per 250 ML InjectionSY9943a961-3b50-4847-8a84-d8414ce38daa27
309986dobutamine 500 MG per 250 ML InjectionSY9943a961-3b50-4847-8a84-d8414ce38daa27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3724-1100409372411250 mL in 1 BAG250 mlHistorical
0409-3724-320040937243212 POUCH in 1 CASE (0409-3724-32) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-3724-11) 12 pouch2005-10-120000-00-00NoNoCurrent