Drug
Who makes mexiletine hydrochloride?
14 companies list mexiletine hydrochloride as a human prescription drug. Forms: capsule. Routes: oral.
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 mexiletine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA074450, ANDA214089, ANDA215315 | 15 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | capsule | ANDAANDA214089 | 3 | 13 |
| Macleods Pharmaceuticals LimitedIndia | capsule | ANDAANDA219987 | 3 | 5 |
| ANI Pharmaceuticals, Inc.United States | capsule | ANDAANDA074450 | 3 | 1 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA216463 | 3 | 1 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA074450 | 3 | 1 |
| Rising Pharma Holdings, Inc.United States | capsule | ANDAANDA215315 | 3 | 1 |
| SENORES PHARMACEUTICALS LIMITEDIndia | capsule | ANDAANDA202111, ANDA214089 | 3 | 1 |
| Amerisyn, LLC | capsule | ANDAANDA214089 | 3 | 0 |
| AvKARE | capsule | ANDAANDA074377 | 3 | 0 |
| Ingenus Pharmaceuticals, LLC | capsule | ANDAANDA214352 | 3 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule | ANDAANDA074377 | 2 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA216463 | 1 | 5 |
| Chartwell RX, LLC. | capsule | ANDAANDA213500 | 1 | 0 |
Bulk ingredient listings
- Alembic Pharmaceuticals LimitedIndia · 1 NDC
- Biophore India Pharmaceuticals Private LimitedIndia · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- KALINTIS HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
- Medichem SASpain · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
Enquiry
Common questions
- Who makes mexiletine hydrochloride?
- 14 companies list mexiletine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Sun Pharmaceutical Industries Limited, Macleods Pharmaceuticals Limited, ANI Pharmaceuticals, Inc., Camber Pharmaceuticals, Inc.. 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 mexiletine hydrochloride?
- 14 companies list mexiletine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies mexiletine hydrochloride active ingredient?
- 7 companies list mexiletine hydrochloride as a bulk ingredient, including Alembic Pharmaceuticals Limited, Biophore India Pharmaceuticals Private Limited, Cohance Lifesciences Limited, Hetero Drugs Limited.