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Data updated: Jun 17, 2026

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (epinephrine)

Adrenergic alpha-Agonists
Other Approved 1972-02-23

Lidocaine Hydrochloride and Epinephrine Injection, USP 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.

Source: FDA Label • BELMORA LLC
Jump to: Indications Approvals Trials Competitors Safety Patents
8
Indications
--
Phase 3 Trials
54
Years on Market

Details

Status
Discontinued
First Approved
1972-02-23
Routes
INJECTION, IONTOPHORESIS, TOPICAL
Dosage Forms
INJECTABLE, SOLUTION

Companies

BELMORA LLC Pfizer B BRAUN MEDICAL WEST-WARD PHARMS INT EMPI EASTMAN KODAK
Active Ingredient: EPINEPHRINE , LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Approval History

1973
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2026
Original
New Indication
New Form
Label Update
153 FDA actions from 1972 to 2026
Apr 2026 SUPPL
Label · Labeling
Sep 2021 ORIGINAL
Update
Jul 2020 SUPPL
Label · Labeling

What LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Treats

8 FDA approvals

Originally approved for its first indication in 1972 . Covers 8 distinct patient populations.

  • Other (8)
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Clinical Trial Registry

56 trials
Trial Sponsor ID Phase Status Title
NCT05738148 Pro00122275 Ph 1 active not recruiting Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation
NCT04432597 200104 20-C-0104 Ph 1, Ph 2 active not recruiting HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers
NCT05488847 results posted 15592 Ph 4 active not recruiting Opioid-Free Pain Protocol After Shoulder Arthroplasty
NCT07092566 IRB00133736 ONC-GU-2404 Ph 3 recruiting R.E.C.K vs Exparel in Robotic Nephrectomy
NCT02118467 14-0047 Ph 4 recruiting Vasoactive Drugs in Intensive Care Unit
NCT06418308 STUDY-23-01613 Ph 4 recruiting Intrathecal Dexmedetomidine vs Epinephrine
NCT03826524 EpiDOSE EpiDOSE Protocol Version 3.0 Ph 4 recruiting Epinephrine Dose: Optimal Versus Standard Evaluation Trial
NCT02356159 results posted 150067 15-C-0067 Ph 1, Ph 2 completed Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
NCT02722746 results posted IRB201600185 Ph 1, Ph 2 completed The Prevention of Hypotension After Epidural Analgesia After Major Surgery
NCT01059786 results posted 100025 10-C-0025 Ph 2 active not recruiting Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia
NCT05972681 PAIN results posted 2023-14825 Ph 4 terminated The PAIN (Pelvic Area Injection for Numbness) Study
NCT03554473 results posted 180110 18-C-0110 Ph 1, Ph 2 completed M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers
NCT04032119 EPI-ESD RCT01 Ph 3 completed RCT of Gastric ESD With or Without Epineprhine Added Solution
NCT03476642 results posted STUDY0008641 Ph 4 completed Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
NCT06264596 2310-72 Ph 3 withdrawn Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery
NCT06013150 DMC-CL-002 Ph 1 completed Study of Inhaled DMC-IH1 and Intramuscular (EpiPen®) Epinephrine in Healthy Male and Female Participants.
NCT06284434 CHI2311 Ph 3 recruiting Liposomal Bupivacaine Use in Alveolar Bone Graft Patients
NCT04594408 PA2018-001 Ph 4 completed Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery
NCT06266962 3/24 Ph 4 completed Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome
NCT02967172 results posted 201608737 Ph 4 completed Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
NCT04065451 results posted 1908473351 Ph 4 completed Effect of Epinephrine on Post-polypectomy Pain
NCT02980835 721921 Ph 4 completed Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries
NCT03513445 ORSU-2018-26340 Ph 3 withdrawn Peri-Incisional Drug Injection in Lumbar Spine Surgery
NCT05439460 results posted 22554 Ph 4 completed Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension
NCT05413902 A9630120 Ph 4 completed Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery
NCT05324995 394048 Ph 2 completed Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty
NCT02570503 results posted HM20004125 Ph 4 terminated Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
NCT02740127 results posted 2014-0990 NCI-2016-00860 Ph 3 completed Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis
NCT03228914 results posted HSC-MS-17-0415 Ph 4 completed Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
NCT02895035 results posted 00005630 Ph 4 terminated Comparison of Epinephrine and Phenylephrine/Ketorolac With Regards to Pupil Size
NCT02453516 2014-0051-E Ph 2, Ph 3 completed The Effect of the Serratus Block on Pain Control After Breast Surgery
NCT03383588 results posted 2017-8094 Ph 2 terminated Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
NCT03163914 Vasopressor Ph 4 completed Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension
NCT02543801 results posted IRB2022 Ph 4 completed A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
NCT02534571 TC325 TC325 Study Ph 3 completed To Compare a Hemostatic Powder TC-325 and Standard Treatment in the Control of Acute Upper Gastrointestinal Bleeding From Nonvariceal Causes
NCT00628550 Vasopressin 082007-065 Ph 1 completed Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation
NCT00890162 results posted 090129 09-I-0129 Ph 2 completed A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
NCT02365961 results posted Pro00038232 Ph 4 completed Hip Scope Fascia-iliaca (FI) Block Study
NCT02519023 results posted 7152222222 Ph 4 completed TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy
NCT02474654 15-009 Ph 4 completed Implementation of a Pain Management Protocol for Total Knee Arthroplasty
NCT02462148 results posted IRB00032807 Ph 4 completed Perineural Steroids for Peripheral Nerve Blocks
NCT02464176 results posted IRB00032805 Ph 4 completed Systemic Steroids for Peripheral Nerve Blocks
NCT03441412 EudraCT 2017-003111-18 Ph 1 completed A Study of the Effect of Epinephrine on Platelet Reactivity in Subjects Treated With Ticagrelor
NCT02658149 results posted 2015-422 Ph 4 completed Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
NCT02242201 results posted 14-004183 UL1TR000135 Ph 4 completed Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular
NCT02428062 THE BRIDGE TB-POCD Ph 2, Ph 3 suspended Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly
NCT02793947 results posted 201501822 Ph 4 completed Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
NCT01759407 results posted IRB16-00338 Ph 2 terminated Femoral Nerve Block for Femur Fracture Repair in Pediatrics
NCT02526199 2014-005383-14 Ph 4 completed Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery
NCT02807298 DYPDCH/IEC-SS/18/2014 Ph 3 completed 4% Articaine and 2% Lidocaine by Intraligamentary Technique in Irreversible Pulpitis

Showing 50 of 56 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE FDA Label Details

Indications & Usage

FDA Label (PDF)

Lidocaine Hydrochloride and Epinephrine Injection, USP 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.

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Data Sources

FDA Approval: ANDA080504 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.