MedPath

Lidocaine Hydrochloride

Approved
Approval ID

ef782e5e-e2d7-465a-99c6-b12611f3158c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2023

Manufacturers
FDA

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
NDC Product Code55150-251
Application NumberANDA207182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-252
Application NumberANDA207182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (6)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-255
Application NumberANDA207182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-256
Application NumberANDA207182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (6)

METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-254
Application NumberANDA207182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (6)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55150-253
Application NumberANDA207182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (6)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/7/2023

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**
****PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2% 1,000 mg per 50 mL (20 mg / mL) - 50 mL Container-Carton Label [25 Vials]

Description Section

LOINC: 34089-3Updated: 9/7/2023

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 Chemical Structure

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.

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