LIDOCAINE HYDROCHLORIDE
Approved
Approval ID
2177b6fe-aa37-6f6b-e063-6294a90af09a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
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 HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1454
Application NumberANDA083158
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/6/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/6/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 9/6/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 9/6/2024
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/6/2024
DESCRIPTION SECTION
LOINC: 34089-3Updated: 9/6/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 9/6/2024
WARNINGS SECTION
LOINC: 34071-1Updated: 9/6/2024
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 9/6/2024
DRUG ABUSE AND DEPENDENCE SECTION
LOINC: 42227-9Updated: 9/6/2024
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 9/6/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/6/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 9/6/2024