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Lidocaine Hydrochloride and Dextrose

Lidocaine Hydrochloride and5% Dextrose Injection USP

Approved
Approval ID

7dff29d9-522d-40eb-a9d9-42377912d640

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2023

Manufacturers
FDA

B. Braun Medical Inc.

DUNS: 002397347

Products 2

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

LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0264-9594
Application NumberNDA019830
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification

INGREDIENTS (3)

DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 0.4 g in 100 mL
Code: EC2CNF7XFP
Classification: ACTIB

LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0264-9598
Application NumberNDA019830
Product Classification
M
Marketing Category
C73594
G
Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification

INGREDIENTS (3)

DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 0.8 g in 100 mL
Code: EC2CNF7XFP
Classification: ACTIB

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Lidocaine Hydrochloride and Dextrose - FDA Drug Approval Details