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LIDOCAINE HCl

LIDOCAINE HCl INJECTION, USP 1% 20mg/2mL (10mg/mL) 2mL AMP

Approved
Approval ID

e39435a3-1f69-78c5-e053-2995a90a7fc3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2024

Manufacturers
FDA

HF Acquisition Co LLC, DBA HealthFirst

DUNS: 045657305

Products 1

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

LIDOCAINE HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51662-1593
Application NumberANDA080408
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HCl
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL, INTRACAUDAL, EPIDURAL
Effective DateJanuary 27, 2024
FDA Product Classification

INGREDIENTS (5)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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LIDOCAINE HCl - FDA Drug Approval Details