LIDOCAINE HCl and EPINEPHRINE
Lidocaine Hydrochloride and Epinephrine Injection, USP
Approved
Approval ID
fc83d701-02b2-4595-8e5b-dbebc5e209d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2021
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LIDOCAINE HCl and EPINEPHRINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0264-9378
Application NumberANDA208475
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HCl and EPINEPHRINE
Product Specifications
Route of AdministrationEPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL
Effective DateDecember 13, 2021
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Quantity: 6.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EPINEPHRINE BITARTRATEActive
Quantity: 0.005 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.219 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 15 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB