1% LIDOCAINE HCI
LIDOCAINE HCI INJECTION, USP 200mg/20mL (10mg/mL), 50mL VIAL, USP 400mg/20mL (20mg/mL) 20mL VIAL
Approved
Approval ID
999b1c7b-3495-926a-e053-2a95a90ab206
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2020
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
1% LIDOCAINE HCI
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1465
Application NumberANDA088299
Product Classification
M
Marketing Category
C73584
G
Generic Name
1% LIDOCAINE HCI
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateFebruary 23, 2020
FDA Product Classification
INGREDIENTS (6)
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
2% LIDOCAINE HCI
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1467
Application NumberANDA088327
Product Classification
M
Marketing Category
C73584
G
Generic Name
2% LIDOCAINE HCI
Product Specifications
Route of AdministrationINFILTRATION, PERINEURAL
Effective DateFebruary 23, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT