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FDA Approval

Lidocaine Hydrochloride and Epinephrine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Henry Schein, Inc.
DUNS: 012430880
Effective Date
March 2, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Epinephrine(5 ug in 1 mL)
Lidocaine(5 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine Hydrochloride and Epinephrine

Product Details

NDC Product Code
0404-9886
Application Number
ANDA089635
Marketing Category
ANDA (C73584)
Route of Administration
INFILTRATION, PERINEURAL
Effective Date
January 11, 2022
Code: YKH834O4BHClass: ACTIBQuantity: 5 ug in 1 mL
LidocaineActive
Code: V13007Z41AClass: ACTIRQuantity: 5 mg in 1 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: .5 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACTQuantity: .2 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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