MedPath

Hextend

Rx only

Approved
Approval ID

fc79700c-6c3b-4998-8307-4dc8c81c5041

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2023

Manufacturers
FDA

Hospira, Inc.

DUNS: 141588017

Products 1

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

HETASTARCH

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0409-1555
Application NumberBN200952
Product Classification
M
Marketing Category
C73594
G
Generic Name
HETASTARCH
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 15, 2023
FDA Product Classification

INGREDIENTS (8)

HETASTARCHActive
Quantity: 6 g in 100 mL
Code: 875Y4127EA
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT

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Hextend - FDA Drug Approval Details