FDA.reportPublic FDA data

DOBUTAMINE

Product NDC
0409-2344
11-digit product format
004092344
Labeler code
0409
Product ID
0409-2344_5d6b1dfe-d679-4aea-97a6-3d074a202afe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOBUTAMINE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA074086
Marketing category
ANDA
Marketing start
2005-04-30
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
12.5 mg/mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOBUTAMINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOBUTAMINE HYDROCHLORIDE12.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WR771DJXV
Rxcui1812168

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c061d745-4e41-be68-87e9-bad2cb726830Product name220240208
020518de-5dfd-f3a9-9c93-8015dad30497Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2344-68DOBUTAMINE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2019
0409-2344-88DOBUTAMINE10 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE1019
0409-2344-01DOBUTAMINE1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE111
0409-2344-01DOBUTAMINE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2011
0409-2344-02DOBUTAMINE10 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE1011
0409-2344-62DOBUTAMINE20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2344-01ML - Milliliter0409-23444273c28c-cc91-4895-9d3e-579c4d46c18b12012-07-24
0409-2344-02ML - Milliliter0409-2344ce5dd6d2-c6a2-4a5d-906c-96a40527d09b12012-07-24
0409-2344-62ML - Milliliter0409-2344a05e2a4c-79bb-405a-a29a-1881bc4ccf4812018-07-03
0409-2344-68ML - Milliliter0409-2344343474af-05f6-4e92-b423-b363e1b16f2312019-07-02
0409-2344-88ML - Milliliter0409-23441208c248-4b37-450d-af25-2c9f13d07fb212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOBUTAMINE HYDROCHLORIDEACTIVE INGREDIENT0WR771DJXVDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3
DOBUTAMINEACTIVE MOIETY3S12J47372DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2344DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]18Current NDC, Legacy NDC, 2 package rows20241211_89becb0c-da60-4f43-0a98-29ff7a9eca58.zip
0409-2344DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11Current NDC, Legacy NDC, 4 package rows20241210_dc537761-d5f4-488d-24ab-b2bcd2b17b7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812168DOBUTamine 250 MG in 20 ML InjectionPSN89becb0c-da60-4f43-0a98-29ff7a9eca5819
181216820 ML dobutamine 12.5 MG/ML InjectionSCD89becb0c-da60-4f43-0a98-29ff7a9eca5819
1812168dobutamine (as dobutamine HCl) 250 MG per 20 ML InjectionSY89becb0c-da60-4f43-0a98-29ff7a9eca5819
1812168dobutamine 250 MG per 20 ML InjectionSY89becb0c-da60-4f43-0a98-29ff7a9eca5819
1812168DOBUTamine 250 MG in 20 ML InjectionPSNdc537761-d5f4-488d-24ab-b2bcd2b17b7a11
181216820 ML dobutamine 12.5 MG/ML InjectionSCDdc537761-d5f4-488d-24ab-b2bcd2b17b7a11
1812168dobutamine (as dobutamine HCl) 250 MG per 20 ML InjectionSYdc537761-d5f4-488d-24ab-b2bcd2b17b7a11
1812168dobutamine 250 MG per 20 ML InjectionSYdc537761-d5f4-488d-24ab-b2bcd2b17b7a11
1812168DOBUTamine 250 MG in 20 ML InjectionPSN7b9ea626-7072-2e77-e053-2a91aa0a92156
181216820 ML dobutamine 12.5 MG/ML InjectionSCD7b9ea626-7072-2e77-e053-2a91aa0a92156
1812168dobutamine (as dobutamine HCl) 250 MG per 20 ML InjectionSY7b9ea626-7072-2e77-e053-2a91aa0a92156
1812168dobutamine 250 MG per 20 ML InjectionSY7b9ea626-7072-2e77-e053-2a91aa0a92156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2344-01004092344011 VIAL, SINGLE-DOSE in 1 CARTON (0409-2344-01) / 20 mL in 1 VIAL, SINGLE-DOSE2005-08-030000-00-00NoNoCurrent
0409-2344-020040923440210 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-62) 2005-06-290000-00-00NoNoCurrent
0409-2344-620040923446220 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0409-2344-680040923446820 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0409-2344-880040923448810 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-88) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-68) 2005-04-300000-00-00NoNoCurrent