FDA.reportPublic FDA data

Dopamine Hydrochloride

Product NDC
0143-9253
11-digit product format
001439253
Labeler code
0143
Product ID
0143-9253_67349236-e8e3-45ec-a76d-2a0a150d8d59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dopamine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA207707
Marketing category
ANDA
Marketing start
2018-04-11
Substance
DOPAMINE HYDROCHLORIDE
Active strength
80 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7L3E358N9L
Rxcui1743938, 1743941, 1743950, 1743953

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9253-01Dopamine Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION53
0143-9253-25Dopamine Hydrochloride25 in 1 CARTONINJECTION253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9253DOPAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20240619_0e499952-46c7-4172-8c70-186312e240a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743938DOPamine HCl 40 MG/ML in 10 ML InjectionPSN0e499952-46c7-4172-8c70-186312e240a33
1743941DOPamine HCl 40 MG/ML in 5 ML InjectionPSN0e499952-46c7-4172-8c70-186312e240a33
1743950DOPamine HCl 80 MG/ML in 10 ML InjectionPSN0e499952-46c7-4172-8c70-186312e240a33
1743953DOPamine HCl 80 MG/ML in 5 ML InjectionPSN0e499952-46c7-4172-8c70-186312e240a33
174393810 ML dopamine hydrochloride 40 MG/ML InjectionSCD0e499952-46c7-4172-8c70-186312e240a33
174395010 ML dopamine hydrochloride 80 MG/ML InjectionSCD0e499952-46c7-4172-8c70-186312e240a33
17439415 ML dopamine hydrochloride 40 MG/ML InjectionSCD0e499952-46c7-4172-8c70-186312e240a33
17439535 ML dopamine hydrochloride 80 MG/ML InjectionSCD0e499952-46c7-4172-8c70-186312e240a33
1743938dopamine HCl 40 MG/ML per 10 ML InjectionSY0e499952-46c7-4172-8c70-186312e240a33
1743941dopamine HCl 40 MG/ML per 5 ML InjectionSY0e499952-46c7-4172-8c70-186312e240a33
1743950dopamine HCl 80 MG/ML per 10 ML InjectionSY0e499952-46c7-4172-8c70-186312e240a33
1743953dopamine HCl 80 MG/ML per 5 ML InjectionSY0e499952-46c7-4172-8c70-186312e240a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9253-01001439253015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0143-9253-250014392532525 VIAL, SINGLE-DOSE in 1 CARTON (0143-9253-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9253-01) 2018-04-110000-00-00NoNoCurrent