FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | c4d92cce-e899-4f14-b19c-5e17f9922215 | 2026-08-06 | Warnings, Adverse reactions | Name/manufacturer search |
| SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | Par Health USA, LLC | 2e13a3b5-e4df-4d5c-9b26-02a7006a7c3e | 2026-04-28 | Warnings, Adverse reactions | Name/manufacturer search |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Par Health USA, LLC | eafec3a2-4f29-4afa-8728-a62b34cefd18 | 2026-04-17 | Warnings, Adverse reactions | Name/manufacturer search |
| Sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 3f0d6820-ff59-40c0-882f-aeea2dd1d1ad | 2026-03-05 | Warnings, Adverse reactions | Name/manufacturer search |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Camber Pharmaceuticals, Inc. | ec8ea96c-8ec1-4301-a85d-d59562e548ca | 2026-02-24 | Warnings, Adverse reactions | Name/manufacturer search |
| Sapropterin Dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | TRUPHARMA, LLC | 39f1d020-4359-401b-88a8-ed25eaa40b45 | 2026-02-18 | Warnings, Adverse reactions | Name/manufacturer search |
| Sapropterin Dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Micro Labs Limited | 907e24c4-3337-4aee-b789-276e37a85cd8 | 2026-01-14 | Warnings, Adverse reactions | Name/manufacturer search |
| Sapropterin Dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Aurobindo Pharma Limited | 11ee25bc-f501-4f9d-b63d-63b2eee0147e | 2025-06-10 | Warnings, Adverse reactions | Name/manufacturer search |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | NorthStar RxLLC | a64a50ba-e3da-4227-9bce-87101d60409e | 2025-01-06 | Warnings, Adverse reactions | Name/manufacturer search |
| Sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | NorthStar RxLLC | b3999f74-920d-4444-afa7-f4211e4eb431 | 2024-07-09 | Warnings, Adverse reactions | Name/manufacturer search |
| SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | Par Health USA, LLC | 6b2172e4-42fc-42fe-b1ad-9d6a974d4343 | 2020-07-09 | Warnings, Adverse reactions | Name/manufacturer search |
| ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | Aucta Pharmaceuticals, Inc. | 8de84882-dd24-46f2-8416-5e492d4275d1 | 2025-04-30 | Warnings, Adverse reactions | Name/manufacturer search |
| JAVYGTOR | SAPROPTERIN DIHYDROCHLORIDE | Dr. Reddys Laboratories Inc | eecdd8c7-5f8a-0af1-793a-db2e2ba0f491 | 2024-10-22 | Warnings, Adverse reactions | Name/manufacturer search |
| JAVYGTOR | SAPROPTERIN DIHYDROCHLORIDE | Dr. Reddys Laboratories Inc | d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4 | 2024-10-21 | Warnings, Adverse reactions | Name/manufacturer search |
| JAVYGTOR | SAPROPTERIN DIHYDROCHLORIDE | Dr. Reddys Laboratories Inc | 1590afa1-baa4-70e5-5a3b-468401c71044 | 2024-10-21 | Warnings, Adverse reactions | Name/manufacturer search |
| Kuvan | SAPROPTERIN DIHYDROCHLORIDE | BioMarin Pharmaceutical Inc. | af38711e-8873-4790-a92d-4d583e23fb89 | 2024-08-26 | Warnings, Adverse reactions | Name/manufacturer search |