Drug
Who makes lidocaine hydrochloride?
54 companies list lidocaine hydrochloride as a human prescription drug, including under the names Accucaine, Eha, Xylocaine, Xylocaine MPF, DermacinRx Lidotral, Lidotral 5 Percent Roll On Gel, Lidotral Five Percent, Lidotral Two Percent. Forms: cream; gel; injection; injection, solution; jelly; lotion; solution; spray. Routes: epidural, infiltration, intracaudal, intravenous, oral, oropharyngeal, perineural, retrobulbar, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing lidocaine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Medical Purchasing Solutions, LLCUnited States | injection; injection, solution; solution | ANDAANDA040302, ANDA080407, ANDA083173 | 20 | 1 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDA, NDAANDA088586, NDA006488, NDA017584 | 15 | 6 |
| Eugia US LLC | injection, solution | ANDAANDA203040, ANDA203082, ANDA207182 | 14 | 0 |
| Hospira, Inc.United States | injection, solution | ANDAANDA040078, ANDA040302, ANDA080408 | 12 | 7 |
| Lifestar Pharma LLC. | injection, solution | ANDAANDA217692, ANDA217693 | 12 | 0 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution; solution | ANDAANDA080407, ANDA084625, ANDA088802 | 11 | 4 |
| Henry Schein, Inc.United States | injection, solution; jelly | ANDA, NDAANDA040302, ANDA086283, ANDA088328 | 11 | 1 |
| International Medication Systems, Ltd.United States | injection; injection, solution; jelly; solution | ANDAANDA080407, ANDA083173, ANDA086283 | 10 | 3 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | injection, solution; lotion | ANDA, NDA, UNAPPROVED DRUG OTHERANDA080408, ANDA084625, ANDA203040 | 9 | 1 |
| PureTek CorporationUnited States | cream; gel; spray | UNAPPROVED DRUG OTHER | 7 | 2 |
| NorthStar RxLLC | injection, solution | ANDAANDA214336, ANDA217692 | 7 | 0 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA040078, ANDA040302, ANDA088299 | 6 | 3 |
| HF Acquisition Co LLCUnited States | injection, solution; jelly | ANDA, NDAANDA083158, ANDA086283, ANDA203082 | 6 | 1 |
| Sportpharm LLC | injection, solution | ANDA, NDAANDA080407, ANDA088586, ANDA203082 | 6 | 0 |
| Huons Co., Ltd.South Korea | solution | ANDAANDA212821 | 4 | 2 |
| Bryant Ranch PrepackUnited States | solution | ANDAANDA040710, ANDA087881, ANDA218411 | 4 | 1 |
| Camber Pharmaceuticals, Inc.United States | injection, solution | ANDAANDA214336, ANDA214339 | 4 | 1 |
| Anthea Pharma Private Limited | injection, solution | ANDAANDA219535 | 4 | 0 |
| Brookfield Pharmaceuticals, LLC. | solution | ANDAANDA212821 | 4 | 0 |
| Cardinal Health 418, Inc.United States | injection, solution | ANDAANDA040302, ANDA088299, ANDA207182 | 3 | 34 |
| NuCare Pharmaceuticals,Inc.United States | solution | ANDAANDA040014, ANDA088802, ANDA216780 | 3 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDAANDA204494, ANDA218138 | 3 | 1 |
| RemedyRepack, IncUnited States | injection; solution | ANDAANDA083173, ANDA088802, ANDA216780 | 3 | 1 |
| Baxter Healthcare CorporationUnited States | injection, solution | NDANDA018461 | 2 | 16 |
| Xttrium Laboratories, Inc.United States | solution | ANDAANDA087872, ANDA087881 | 2 | 2 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | injection, solution | ANDA, UNAPPROVED DRUG OTHERANDA203082 | 2 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection, solution | ANDAANDA084625 | 2 | 1 |
| Preferred Pharmaceuticals Inc.United States | solution | ANDAANDA216780, ANDA218138 | 2 | 1 |
| South Atlantic Corporation LLCUnited States | solution | ANDAANDA216780 | 2 | 1 |
| Avenacy, Inc. | injection, solution | ANDAANDA219535 | 2 | 0 |
| Chartwell RX, LLC. | solution | ANDAANDA040708 | 2 | 0 |
| Mckesson Corporation DBA SKY Packaginng | solution | ANDAANDA204494, ANDA212821 | 2 | 0 |
| Novagenix Labs LLC | solution | ANDAANDA212821 | 2 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | solution | ANDAANDA218182 | 1 | 13 |
| Aurobindo Pharma LimitedIndia | solution | ANDAANDA219759 | 1 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | solution | ANDAANDA216780 | 1 | 5 |
| B. Braun US Pharmaceutical Manufacturing LLCUnited States | injection | ANDAANDA208474 | 1 | 3 |
| Novitium Pharma LLCUnited States | solution | ANDAANDA216250 | 1 | 2 |
| SENTISS PHARMA PRIVATE LIMITEDIndia | jelly | ANDAANDA040433 | 1 | 2 |
| Golden State Medical Supply Inc.United States | solution | ANDAANDA088803 | 1 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection, solution | ANDAANDA215132 | 1 | 1 |
| Lannett Company, LLCUnited States | solution | ANDAANDA040710 | 1 | 1 |
| Marlex Pharmaceuticals, IncUnited States | solution | ANDAANDA216250 | 1 | 1 |
| Precision Dose Inc.United States | solution | ANDAANDA212821 | 1 | 1 |
| Proficient Rx LPUnited States | cream | UNAPPROVED DRUG OTHER | 1 | 1 |
| Trifluent Pharma LLCUnited States | cream | UNAPPROVED DRUG OTHER | 1 | 1 |
| Advagen Pharma Limited | solution | ANDAANDA216780 | 1 | 0 |
| Armas Pharmaceuticals, Inc. | jelly | ANDAANDA040433 | 1 | 0 |
| Chartwell Governmental & Specialty RX, LLC. | solution | ANDAANDA040708 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | solution | ANDAANDA218138 | 1 | 0 |
| Sagent Pharmaceuticals | jelly | ANDAANDA201094 | 1 | 0 |
| Seton Pharmaceuticals, LLC | cream | UNAPPROVED DRUG OTHER | 1 | 0 |
| The J. Molner Company LLC | solution | ANDAANDA218411 | 1 | 0 |
| Westminster Pharmaceuticals, LLC | cream | UNAPPROVED DRUG OTHER | 1 | 0 |
Bulk ingredient listings
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 6 NDC
- ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States · 2 NDC
- HAWAII REPACK INCUnited States · 2 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Spectrum Pharmaceuticals, Inc.United States · 2 NDC
- Swati Spentose Pvt. Ltd.India · 2 NDC
- Cambrex Karlskoga ABSweden · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- Hetero Labs LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Moehs Catalana SLSpain · 1 NDC
- Supriya Lifescience LimitedIndia · 1 NDC
- W. R. GRACE & CO.-CONN.United States · 1 NDC
Orange Book patents
3 unexpired patents list lidocaine hydrochloride as the active ingredient, expiring between Oct 2029 and Sept 2035. Application holder: POWDER PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes lidocaine hydrochloride?
- 54 companies list lidocaine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Medical Purchasing Solutions, LLC, Fresenius Kabi USA, LLC, Eugia US LLC, Hospira, Inc., Lifestar Pharma LLC.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Accucaine?
- 48 companies list lidocaine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 6 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies lidocaine hydrochloride active ingredient?
- 15 companies list lidocaine hydrochloride as a bulk ingredient, including ASCLEMED USA INC. DBA ENOVACHEM, ADVANCED RX PHARMACY OF TENNESSEE LLC, HAWAII REPACK INC, Professional Compounding Centers of America dba PCCA.