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Dopamine Hydrochloride

DOPamine HYDROCHLORIDE Injection, USPRx onlyFliptop VialMUST BE DILUTED PRIOR TO ADMINISTRATION

Approved
Approval ID

fc1eb709-ce72-413e-9043-8e463ef0fd36

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 13, 2023

Manufacturers
FDA

Henry Schein, Inc.

DUNS: 012430880

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dopamine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0404-9981
Application NumberNDA018132
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 17, 2022
FDA Product Classification

INGREDIENTS (4)

Dopamine HydrochlorideActive
Quantity: 40 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
Sodium MetabisulfiteInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 10 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 5 mg in 1 mL
Code: B22547B95K
Classification: IACT

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Dopamine Hydrochloride - FDA Drug Approval Details