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Lidocaine Hydrochloride and Epinephrine

Lidocaine Hydrochloride and Epinephrine Injection, USP

Approved
Approval ID

d2d1773a-1365-42bf-bded-c2dafe3fee77

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 Code61699-3182
Application NumberANDA089646
Product Classification
M
Marketing Category
C73584
G
Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE
Product Specifications
Route of AdministrationINFILTRATION
Effective DateJune 10, 2014
FDA Product Classification

INGREDIENTS (9)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EPINEPHRINEActive
Quantity: 10 ug in 1 mL
Code: YKH834O4BH
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 0.2 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
LIDOCAINE HYDROCHLORIDE ANHYDROUSActive
Quantity: 20 mg in 1 mL
Code: EC2CNF7XFP
Classification: ACTIB

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Lidocaine Hydrochloride and Epinephrine - FDA Drug Approval Details