Lidocaine Hydrochloride and Epinephrine
Lidocaine Hydrochloride and Epinephrine Injection, USP
Approved
Approval ID
96773b3d-3eed-4bc9-aac0-18c185377cad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2014
Manufacturers
FDA
US MedSource, LLC
DUNS: 032793851
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61699-3178
Application NumberANDA089644
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE
Product Specifications
Route of AdministrationINFILTRATION
Effective DateJune 12, 2014
FDA Product Classification
INGREDIENTS (9)
EPINEPHRINEActive
Quantity: 10 ug in 1 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 7 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 10 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB