Drug
Who makes labetalol hydrochloride?
40 companies list labetalol hydrochloride as a human prescription drug. Forms: injection; injection, solution; tablet; tablet, film coated. Routes: intravenous, 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 labetalol hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA075215, ANDA200908, ANDA207743 | 21 | 1 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA075133, ANDA075215, ANDA200908 | 13 | 3 |
| Hikma Pharmaceuticals USA Inc.United States | injection; injection, solution | ANDA, NDAANDA075303, NDA213330 | 8 | 4 |
| Cardinal Health 418, Inc.United States | injection, solution; tablet, film coated | ANDAANDA075239, ANDA207743, ANDA209603 | 6 | 34 |
| BluePoint Laboratories Inc. | tablet; tablet, film coated | ANDAANDA074787, ANDA207743 | 6 | 0 |
| Method Pharmaceuticals, LLC. | tablet, film coated | ANDAANDA075215 | 6 | 0 |
| Biocon Biologics LimitedIndia | tablet, film coated | ANDAANDA209603 | 4 | 9 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | tablet | ANDAANDA074787 | 4 | 1 |
| Advagen Pharma Limited | tablet, film coated | ANDAANDA211953 | 4 | 0 |
| Northstar Rx, LLC, | injection, solution; tablet | ANDAANDA074787, ANDA214533 | 4 | 0 |
| Baxter Healthcare CorporationUnited States | injection, solution | ANDAANDA076051 | 3 | 16 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA207743 | 3 | 12 |
| Macleods Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA217949 | 3 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA207743 | 3 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated | ANDAANDA212719 | 3 | 5 |
| Cadila Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA211325 | 3 | 3 |
| Epic Laboratories, LLCUnited States | tablet | ANDAANDA212990 | 3 | 3 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA209603 | 3 | 1 |
| Innogenix, LLC.United States | tablet, film coated | ANDAANDA075215 | 3 | 1 |
| RemedyRepack, IncUnited States | tablet, film coated | ANDAANDA075215, ANDA209603, ANDA211953 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA207743 | 3 | 1 |
| Chartwell RX, LLC. | tablet | ANDAANDA074787 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA209603 | 3 | 0 |
| Hospira, Inc.United States | injection, solution | ANDAANDA075239, ANDA075240 | 2 | 7 |
| ONESOURCE SPECIALTY PHARMA LIMITEDIndia | injection | ANDAANDA079134 | 2 | 3 |
| CAPLIN STERILES LIMITEDIndia | injection, solution | ANDAANDA214533 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA209603 | 2 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA075133, ANDA209603 | 2 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA209603, ANDA211953 | 2 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated | ANDAANDA209603, ANDA211953 | 2 | 1 |
| Fosun Pharma USA Inc. | injection | ANDAANDA090699 | 2 | 0 |
| Mullan Pharmaceutical Inc. | injection | ANDAANDA090699 | 2 | 0 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA090699 | 1 | 4 |
| Amneal Ireland LimitedIreland | injection, solution | ANDAANDA218870 | 1 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection | ANDAANDA075303 | 1 | 1 |
| Coupler LLCUnited States | tablet | ANDAANDA074787 | 1 | 1 |
| Northwind Health Company, LLCUnited States | tablet, film coated | ANDAANDA209603 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated | ANDAANDA209603 | 1 | 1 |
| Armas Pharmaceuticals, Inc. | injection, solution | ANDAANDA214533 | 1 | 0 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA214533 | 1 | 0 |
Bulk ingredient listings
- Spectrum Pharmaceuticals, Inc.United States · 2 NDC
- Alivus Life Sciences Limited · 1 NDC
- CAMBREX PROFARMACO MILANO SRLItaly · 1 NDC
- COSMA SpA · 1 NDC
- Cadila Pharmaceuticals LimitedIndia · 1 NDC
- Derivados Quimicos SAUSpain · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- PROCOS SpAItaly · 1 NDC
- Pacific Medical Industries LtdUnited States · 1 NDC
- SRINI PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
- Viyash Scientific LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes labetalol hydrochloride?
- 40 companies list labetalol hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., Hikma Pharmaceuticals USA Inc., Cardinal Health 418, Inc., BluePoint Laboratories 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 labetalol hydrochloride?
- 40 companies list labetalol hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies labetalol hydrochloride active ingredient?
- 14 companies list labetalol hydrochloride as a bulk ingredient, including Spectrum Pharmaceuticals, Inc., Alivus Life Sciences Limited, CAMBREX PROFARMACO MILANO SRL, COSMA SpA.