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DOPAMINE HCI IN 5% DEXTROSE

DOPAMINE HCI IN 5% DEXTROSE INJECTION, USP 800mg/500mL (1,600mcg/mL) 500mL BAG

Approved
Approval ID

9989b253-dcf5-7318-e053-2995a90a2890

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2024

Manufacturers
FDA

HF Acquisition Co LLC, DBA HealthFirst

DUNS: 045657305

Products 1

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

DOPAMINE HCI IN 5% DEXTROSE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51662-1458
Application NumberNDA018826
Product Classification
M
Marketing Category
C73594
G
Generic Name
DOPAMINE HCI IN 5% DEXTROSE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 27, 2024
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
DOPAMINE HYDROCHLORIDEActive
Quantity: 1.6 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB

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DOPAMINE HCI IN 5% DEXTROSE - FDA Drug Approval Details