Lidocaine


Hydrochloride Injection, USP

Lidocaine hydrochloride is a short-acting amide-type local anesthetic with a rapid onset and short duration of action and contains no preservatives.

  • Lidocaine Hydrochloride Injection, USP 1% Sintetica

  • Lidocaine Hydrochloride Injection, USP 2% Sintetica

  • Lidocaine Hydrochloride Injection, USP 4% Sintetica

  • For infiltration and nerve block

    Solution for Injection - Clear and colourless solution – Preservatives free – Single dose ampoule

    Indication and usage

    Lidocaine Hydrochloride Injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

    Qualitative and quantitative composition

    Lidocaine Hydrochloride Injection, USP solution is for single dose usage, and is Methyl Paraben Free (Preservative-Free).Lidocaine Hydrochloride Injection, USP solution is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid

    Nature and contents of container

    • Clear glass ampule, glass type 1, USP


    Special precautions for storage

    • Store at Room Temperature

HOW SUPPLIED
Lidocaine Hydrochloride Injection, 1% (10mg per mL)

Unit of sale Strength Each
NDC 83090-001-10
Unit of 10
1% (20 mg per 2 mL)
(10mg per mL)
2 mL Single-Dose Ampule
NDC 83090-002-10
Unit of 10
1% (50 mg per 5 mL)
(10mg per mL)
5 mL Single-Dose Ampule
NDC 83090-003-10
Unit of 10
1% (100 mg per 10 mL)
(10mg per mL)
10 mL Single-Dose Ampule

Lidocaine Hydrochloride Injection, 2% (20mg per mL)

Unit of sale Strength Each
NDC 83090-004-10
Unit of 10
2% (40 mg per 2 mL)
(20mg per mL)
2 mL Single-Dose Ampule
NDC 83090-005-10
Unit of 10
2% (100 mg per 5 mL)
(20mg per mL)
5 mL Single-Dose Ampule
NDC 83090-006-10
Unit of 10
2% (200 mg per 10 mL)
(20mg per mL)
10 mL Single-Dose Ampule


To report suspected adverse reactions, contact Sintetica US, at +1-888-815-3345 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • Only for topical use and retrobulbar injection

    Solution for Injection - Clear and colourless solution – Preservatives free – Single dose ampoule

    Indication and usage

    Lidocaine Hydrochloride Injection 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract or the genito-urinary tract. It may be injected trans-tracheally to anesthetize the larynx and trachea, and it may be administered by retrobulbar injection to provide anesthesia for ophthalmic surgery.

    Qualitative and quantitative composition

    • Each 1 ml contains 40.0 mg of lidocaine hydrochloride in water for injection

    • May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.5 (5.0 to 7.0)

    Nature and contents of container

    • Clear glass ampoule, glass type 1, USP

    Special precautions for storage

    • Store at Room Temperature

HOW SUPPLIED
Lidocaine Hydrochloride Injection, 4% (40mg/mL)

Unit of sale Concentration
NDC 83090-007-10
pack of 10 single-dose ampules
5 mL ampule (200 mg/5 mL)
4%
200 mg/5 mL
(40mg per mL)


To report suspected adverse reactions, contact Sintetica US, at +1-888-815-3345 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Product information

NDC NUMBERSTRENGTHUNIT SIZEPACK QUANTITYABCCARDINALMCKBAR CODED
83090-001-101%
20mg per 2mL
2 mL10 ampules1028839059054922928695
83090-002-101%
50mg per 5mL
5 mL10 ampules1028835159055002928778
83090-003-101%
100mg per 10mL
10 mL10 ampules1028837059054842928786
83090-004-102%
40mg per 2mL
2 mL10 ampules1028830059055262928802
83090-005-102%
100mg per 5mL
5 mL10 ampules1028833559055342928828
83090-006-102%
200mg per 10mL
10 mL10 ampules1028824959055182928851
83090-007-104%
200mg per 5mL
5 mL10 ampules1028835059055422928877
Injectable drugs Sintetica US
Preservative free Sintetica US

Injectable

Preservative-free

Single use Sintetica US
Storage condition: room temperature Sintetica US

Storage condition:
room temperature

Single use