FDA.reportPublic FDA data

Dopamine Hydrochloride in Dextrose

Product NDC
0409-0042
11-digit product format
004090042
Labeler code
0409
Product ID
0409-0042_188ce800-ff3a-4b22-9a95-2273c3bc99ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dopamine Hydrochloride in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018826
Marketing category
NDA
Marketing start
2025-11-03
Substance
DOPAMINE HYDROCHLORIDE
Active strength
1.6 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE1.6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7L3E358N9L
Rxcui1292887, 1743877, 1743879

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0042-01Dopamine Hydrochloride in Dextrose250 mL in 1 BAGINJECTION, SOLUTION25027
0409-0042-12Dopamine Hydrochloride in Dextrose12 in 1 CASEINJECTION, SOLUTION1227
0409-0042-12Dopamine Hydrochloride in Dextrose1 in 1 POUCHINJECTION, SOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0042-01ML - Milliliter0409-00426c026958-7514-46ca-a4a5-cca58071ee5712025-12-16
0409-0042-12ML - Milliliter0409-00429f10fdfa-eb81-4785-b967-daf629b3953d12025-12-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOPAMINE HYDROCHLORIDEACTIVE INGREDIENT7L3E358N9LDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
DOPAMINEACTIVE MOIETYVTD58H1Z2XDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSN08f23f6e-150d-45ea-098e-f2edf64c21a127
1743879DOPamine HCl 1600 MCG/ML in 500 ML InjectionPSN08f23f6e-150d-45ea-098e-f2edf64c21a127
1292887DOPamine HCl 3200 MCG/ML in 250 ML InjectionPSN08f23f6e-150d-45ea-098e-f2edf64c21a127
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD08f23f6e-150d-45ea-098e-f2edf64c21a127
1292887250 ML dopamine hydrochloride 3.2 MG/ML InjectionSCD08f23f6e-150d-45ea-098e-f2edf64c21a127
1743879500 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD08f23f6e-150d-45ea-098e-f2edf64c21a127
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSY08f23f6e-150d-45ea-098e-f2edf64c21a127
1743879dopamine HCl 1600 MCG/ML per 500 ML InjectionSY08f23f6e-150d-45ea-098e-f2edf64c21a127
1292887dopamine HCl 3200 MCG/ML per 250 ML InjectionSY08f23f6e-150d-45ea-098e-f2edf64c21a127
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSN513f7cfb-091a-f8c0-e063-6394a90a0fe21
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD513f7cfb-091a-f8c0-e063-6394a90a0fe21
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSY513f7cfb-091a-f8c0-e063-6394a90a0fe21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-0042-0100409004201250 mL in 1 BAG250 mlHistorical
0409-0042-120040900421212 POUCH in 1 CASE (0409-0042-12) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-0042-01) 12 pouch2025-11-03NoNoCurrent