Drug
Who makes hydromorphone hydrochloride?
17 companies list hydromorphone hydrochloride as a human prescription drug, including under the names Dilaudid. Forms: injection; injection, solution; solution; suppository; tablet; tablet, extended release. Routes: intramuscular, intravenous, oral, rectal, subcutaneous.
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 hydromorphone hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection; injection, solution; solution | ANDA, NDA, UNAPPROVED DRUG OTHERANDA074653, ANDA202159, ANDA216899 | 8 | 4 |
| Rhodes Pharmaceuticals LLC | solution; tablet | NDA, NDA AUTHORIZED GENERICNDA019891, NDA019892 | 8 | 0 |
| Hospira, Inc.United States | injection, solution | ANDA, NDAANDA078591, NDA200403 | 7 | 7 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | NDANDA019034 | 7 | 6 |
| Padagis Israel Pharmaceuticals LtdUnited States | suppository; tablet, extended release | ANDA, UNAPPROVED DRUG OTHERANDA204278 | 5 | 2 |
| Ascent Pharmaceuticals IncUnited States | solution; tablet | ANDAANDA210176, ANDA210506 | 4 | 1 |
| Bryant Ranch PrepackUnited States | suppository; tablet | ANDA, NDA AUTHORIZED GENERIC, UNAPPROVED DRUG OTHERANDA205814, NDA019892 | 4 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet, extended release | ANDAANDA212133 | 4 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet, extended release | ANDAANDA212133 | 4 | 1 |
| Trigen Laboratories, LLC | tablet, extended release | ANDAANDA205629 | 4 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | solution; tablet | ANDA, NDA AUTHORIZED GENERICANDA076855, NDA019891 | 3 | 5 |
| SpecGx LLCUnited States | tablet | ANDAANDA076855 | 3 | 5 |
| Aurolife Pharma LLCUnited States | tablet | ANDAANDA205814 | 3 | 3 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | NDA AUTHORIZED GENERICNDA019892 | 3 | 1 |
| Teva Parenteral Medicines, Inc. | injection, solution | ANDAANDA078591 | 3 | 0 |
| RedPharm DrugUnited States | tablet | ANDAANDA076855 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet | NDA AUTHORIZED GENERICNDA019892 | 1 | 1 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 3 NDC
- Cambrex Charles City, Inc. · 1 NDC
- Chattem Chemicals, Inc.United States · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- Janssen Pharmaceuticals Sciences Unlimited Company · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- Purisys LLCUnited States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- SpecGx LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
3 unexpired patents list hydromorphone hydrochloride as the active ingredient, expiring between Apr 2032 and Jan 2043. Application holders: FRESENIUS KABI USA LLC, HIKMA PHARMACEUTICALS USA INC.
Enquiry
Common questions
- Who makes hydromorphone hydrochloride?
- 17 companies list hydromorphone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Rhodes Pharmaceuticals LLC, Hospira, Inc., Fresenius Kabi USA, LLC, Padagis Israel Pharmaceuticals Ltd. 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 Dilaudid?
- 13 companies list hydromorphone hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies hydromorphone hydrochloride active ingredient?
- 12 companies list hydromorphone hydrochloride as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Cambrex Charles City, Inc., Chattem Chemicals, Inc., Fagron Services B.V..