FDA.reportPublic FDA data

dopamine hydrochloride in dextrose

Product NDC
51662-1681
11-digit product format
516621681
Labeler code
51662
Product ID
51662-1681_513f7cfb-091b-f8c0-e063-6394a90a0fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dopamine hydrochloride in dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA018826
Marketing category
NDA
Marketing start
2025-11-05
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
Rxcui1743877

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
51662-1681-1dopamine hydrochloride in dextrose250 mL in 1 BAGINJECTION, SOLUTION2501
51662-1681-2dopamine hydrochloride in dextrose1 in 1 POUCHINJECTION, SOLUTION11
51662-1681-3dopamine hydrochloride in dextrose12 in 1 CASEINJECTION, SOLUTION121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
51662-1681-151662168101250 mL in 1 BAG250 mlHistorical
51662-1681-2516621681021 in 1 POUCHHistorical
51662-1681-35166216810312 POUCH in 1 CASE (51662-1681-3) / 1 BAG in 1 POUCH (51662-1681-2) / 250 mL in 1 BAG (51662-1681-1) 12 pouch2025-11-05NoNoHistorical