Drug
Who makes midazolam hydrochloride?
19 companies list midazolam hydrochloride as a human prescription drug. Forms: injection, solution; syrup. Routes: intramuscular, 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 midazolam hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ONESOURCE SPECIALTY PHARMA LIMITEDIndia | injection, solution | ANDAANDA090315, ANDA090316 | 7 | 3 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA075154, ANDA203460 | 6 | 6 |
| Hospira, Inc.United States | injection, solution | ANDAANDA075293, ANDA075857 | 5 | 7 |
| STERISCIENCE SP Z O OPoland | injection, solution | ANDAANDA090316 | 3 | 1 |
| Somerset Therapeutics Private LimitedIndia | injection, solution | ANDAANDA090315, ANDA090316 | 3 | 1 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA090696, ANDA090850, ANDA218993 | 3 | 0 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA090696, ANDA090850 | 2 | 4 |
| International Medication Systems, Ltd.United States | injection, solution | ANDAANDA075293 | 2 | 3 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection, solution | ANDAANDA090696, ANDA090850 | 2 | 1 |
| Precision Dose Inc.United States | syrup | ANDAANDA075873 | 2 | 1 |
| Cardinal Health 418, Inc.United States | injection, solution | ANDAANDA075857 | 1 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | syrup | ANDAANDA075873 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | syrup | ANDAANDA075873 | 1 | 4 |
| Padagis Israel Pharmaceuticals LtdUnited States | syrup | ANDAANDA076379 | 1 | 2 |
| Bryant Ranch PrepackUnited States | syrup | ANDAANDA076379 | 1 | 1 |
| Henry Schein, Inc.United States | injection, solution | ANDAANDA075857 | 1 | 1 |
| Jvet Pharmaceuticals LLCUnited States | injection, solution | ANDAANDA090850 | 1 | 1 |
| RemedyRepack, IncUnited States | injection, solution | ANDAANDA090315 | 1 | 1 |
| Belcher Pharmaceuticals, LLC | injection, solution | ANDAANDA090850 | 1 | 0 |
Bulk ingredient listings
- Cohance Lifesciences LimitedIndia · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
Enquiry
Common questions
- Who makes midazolam hydrochloride?
- 19 companies list midazolam hydrochloride as a human prescription drug in the openFDA NDC Directory, led by ONESOURCE SPECIALTY PHARMA LIMITED, Fresenius Kabi USA, LLC, Hospira, Inc., STERISCIENCE SP Z O O, Somerset Therapeutics Private Limited. 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 midazolam hydrochloride?
- 19 companies list midazolam 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 midazolam hydrochloride active ingredient?
- 2 companies list midazolam hydrochloride as a bulk ingredient, including Cohance Lifesciences Limited, FIS FABBRICA ITALIANA SINTETICI SPA.