Lidocaine Hydrochloride
ef782e5e-e2d7-465a-99c6-b12611f3158c
HUMAN PRESCRIPTION DRUG LABEL
Sep 7, 2023
Eugia US LLC
DUNS: 968961354
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Lidocaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2% 1,000 mg per 50 mL (20 mg/mL) -
50 mL Container-Carton Label [25 Vials]
** NDC55150-256-50
2% Lidocaine
** HCl Injection, USP
** 1,000 mg per 50 mL Rx only**
** (20 mg/mL)**
** For Infiltration and Nerve Block.**
** Not for Caudal or Epidural Use.**
** Methylparaben as preservative**
** Sterile 25 x 50 mL**
** Nonpyrogenic Multiple-Dose Vials**
****
Description Section
DESCRIPTION
Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. SeeINDICATIONS AND USAGE section for specific uses.
Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C14H22N2O • HCl) has the following structural formula:
Lidocaine hydrochloride USP is a white, odorless, crystalline powder.
Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, clear, colorless, isotonic solution containing sodium chloride. Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of the solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid.