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FDA Approval

Lidocaine Hydrochloride

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

FDA Approval Summary

Company

Lifestar Pharma LLC

DUNS: 080268943

Effective Date

November 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lidocaine(20 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Mankind Pharma Limited

DUNS Number

915834068

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Mankind Pharma Limited

Labeler

Lifestar Pharma LLC

Registrant

Mankind Pharma Limited

DUNS Number

916512493

Products7

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

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-667

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 20 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 6 mg in 1 mL

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-666

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 10 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-646

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 10 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-645

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 10 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-644

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 10 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-648

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 6 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 20 mg in 1 mL

Lidocaine Hydrochloride

Product Details

NDC Product Code

70756-647

Application Number

ANDA217693

Marketing Category

ANDA (C73584)

Route of Administration

INFILTRATION, PERINEURAL

Effective Date

November 1, 2023

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 6 mg in 1 mL

LidocaineActive

Code: V13007Z41AClass: ACTIRQuantity: 20 mg in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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