FDA.reportPublic FDA data

DOPamine Hydrochloride

Product NDC
0409-9104
11-digit product format
004099104
Labeler code
0409
Product ID
0409-9104_7a125e39-1ecb-4c76-931a-efc9b5921d1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dopamine Hydrochloride
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018132
Marketing category
NDA
Marketing start
2005-06-30
Substance
DOPAMINE HYDROCHLORIDE
Active strength
40 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7L3E358N9L
Rxcui1743938, 1743941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-9104-20DOPamine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION, CONCENTRATE2522
0409-9104-21DOPamine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9104-20ML - Milliliter0409-910436f71d0b-99f7-4b02-82d5-b9fbed4fe8f712012-07-24
0409-9104-21ML - Milliliter0409-9104511eb5d9-ee01-466b-9108-73cdd8b8037112019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOPAMINE HYDROCHLORIDEACTIVE INGREDIENT7L3E358N9LDOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11
DOPAMINEACTIVE MOIETYVTD58H1Z2XDOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-9104DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]21Current NDC, Legacy NDC, 2 package rows20241105_1f306ad2-3606-4525-5a8a-ce78f426c1a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743938DOPamine HCl 40 MG/ML in 10 ML InjectionPSN1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743941DOPamine HCl 40 MG/ML in 5 ML InjectionPSN1f306ad2-3606-4525-5a8a-ce78f426c1a222
174393810 ML dopamine hydrochloride 40 MG/ML InjectionSCD1f306ad2-3606-4525-5a8a-ce78f426c1a222
17439415 ML dopamine hydrochloride 40 MG/ML InjectionSCD1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743938dopamine HCl 40 MG/ML per 10 ML InjectionSY1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743941dopamine HCl 40 MG/ML per 5 ML InjectionSY1f306ad2-3606-4525-5a8a-ce78f426c1a222
1743938DOPamine HCl 40 MG/ML in 10 ML InjectionPSNfc1eb709-ce72-413e-9043-8e463ef0fd3610
174393810 ML dopamine hydrochloride 40 MG/ML InjectionSCDfc1eb709-ce72-413e-9043-8e463ef0fd3610
1743938dopamine HCl 40 MG/ML per 10 ML InjectionSYfc1eb709-ce72-413e-9043-8e463ef0fd3610
1743938DOPamine HCl 40 MG/ML in 10 ML InjectionPSN74205252-3949-57fa-e053-2991aa0aee4d7
174393810 ML dopamine hydrochloride 40 MG/ML InjectionSCD74205252-3949-57fa-e053-2991aa0aee4d7
1743938dopamine HCl 40 MG/ML per 10 ML InjectionSY74205252-3949-57fa-e053-2991aa0aee4d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-9104-200040991042025 VIAL, SINGLE-DOSE in 1 TRAY (0409-9104-20) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9104-21) 2005-06-300000-00-00NoNoCurrent
0409-9104-210040991042110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical