Dobutamine
Dobutamine Injection, USP
Approved
Approval ID
9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2023
Manufacturers
FDA
Hainan Poly Pharm. Co., Ltd.
DUNS: 654561638
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dobutamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14335-171
Application NumberANDA216131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dobutamine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 2, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM METABISULFITEInactive
Quantity: 0.2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 mL
Code: 0WR771DJXV
Classification: ACTIM
Dobutamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14335-172
Application NumberANDA216131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dobutamine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 2, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM METABISULFITEInactive
Quantity: 0.2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 mL
Code: 0WR771DJXV
Classification: ACTIM