Drug
Who makes morphine sulfate?
25 companies list morphine sulfate as a human prescription drug, including under the names Duramorph, INFUMORPH 200, INFUMORPH 500, MS Contin, MITIGO. Forms: capsule, extended release; injection; injection, solution; solution; suppository; tablet; tablet, extended release; tablet, film coated, extended release. Routes: epidural, intramuscular, intrathecal, intravenous, oral, rectal.
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 morphine sulfate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | solution; suppository; tablet; tablet, film coated, extended release | ANDA, UNAPPROVED DRUG OTHERANDA074769, ANDA074862, ANDA078761 | 26 | 1 |
| Hikma Pharmaceuticals USA Inc.United States | injection; injection, solution; solution; tablet | ANDA, NDAANDA205758, ANDA211452, NDA018565 | 14 | 4 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | NDANDA204223 | 11 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | solution; tablet; tablet, film coated, extended release | ANDA, NDAANDA074862, ANDA203518, ANDA206573 | 10 | 5 |
| Upsher-Smith Laboratories, Inc. | capsule, extended release; tablet | ANDAANDA202104, ANDA210610 | 9 | 0 |
| SpecGx LLCUnited States | solution; tablet; tablet, extended release | ANDAANDA076412, ANDA076438, ANDA202348 | 8 | 5 |
| Rhodes Pharmaceuticals LLC | tablet, film coated, extended release | ANDA, NDAANDA074769, ANDA074862, NDA019516 | 8 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule, extended release | ANDAANDA200411 | 7 | 14 |
| Hospira, Inc.United States | injection, solution | ANDA, NDAANDA073509, ANDA073510, NDA202515 | 7 | 7 |
| Precision Dose Inc.United States | solution | NDANDA022195 | 7 | 1 |
| Actavis LLCUnited States | capsule, extended release | ANDAANDA079040 | 6 | 1 |
| Nortec Development Associates, Inc. | capsule, extended release | ANDAANDA203158 | 6 | 0 |
| Lupin LimitedIndia | tablet, film coated, extended release | ANDAANDA203602 | 5 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated, extended release | ANDAANDA078761 | 5 | 13 |
| Padagis Israel Pharmaceuticals LtdUnited States | suppository | UNAPPROVED DRUG OTHER | 4 | 2 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated, extended release | ANDAANDA074769, ANDA074862 | 4 | 0 |
| WINDER LABORATORIES, LLCUnited States | solution | ANDAANDA211454 | 3 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDA, NDAANDA206573, NDA022195 | 2 | 1 |
| Piramal Critical Care IncUnited States | injection | ANDAANDA204393 | 2 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA212451 | 2 | 0 |
| International Medication Systems, Ltd.United States | injection | ANDAANDA202861 | 1 | 3 |
| Civica, Inc. dba CivicaRxUnited States | injection | ANDAANDA205758 | 1 | 1 |
| Cranbury Pharmaceuticals IncUnited States | solution | ANDAANDA203518 | 1 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA215194 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet | ANDAANDA212451 | 1 | 1 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- SpecGx LLCUnited States · 2 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Veranova, L.P.United States · 1 NDC
Orange Book patents
7 unexpired patents list morphine sulfate as the active ingredient, expiring between Aug 2028 and Mar 2034. Application holders: FRESENIUS KABI USA LLC, OHEMO LIFE SCIENCES INC, ZYLA LIFE SCIENCES US INC.
Enquiry
Common questions
- Who makes morphine sulfate?
- 25 companies list morphine sulfate as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC, Pharma Packaging Solutions, LLC dba Tjoapack, LLC, Upsher-Smith 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 Duramorph?
- 22 companies list morphine sulfate under an abbreviated new drug application (ANDA), the application type used for generics, and 7 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies morphine sulfate active ingredient?
- 8 companies list morphine sulfate as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, SpecGx LLC, LETCO MEDICAL, LLC, MEDISCA Inc..