sapropterin dihydrochloride 100 MG Oral Tablet
- RxCUI
- 1486687
- RxNorm name
- sapropterin dihydrochloride 100 MG Oral Tablet
- Display name
- sapropterin dihydrochloride 100 MG Oral Tablet
- Full name
- sapropterin dihydrochloride 100 MG Oral Tablet
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:16
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Par Health USA, LLC | eafec3a2-4f29-4afa-8728-a62b34cefd18 | 2026-04-17 | Warnings, Adverse reactions | 1486687 |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Camber Pharmaceuticals, Inc. | ec8ea96c-8ec1-4301-a85d-d59562e548ca | 2026-02-24 | Warnings, Adverse reactions | 1486687 |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | c4d92cce-e899-4f14-b19c-5e17f9922215 | 2025-07-31 | Warnings, Adverse reactions | 1486687 |
| Sapropterin Dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | Aurobindo Pharma Limited | 11ee25bc-f501-4f9d-b63d-63b2eee0147e | 2025-06-10 | Warnings, Adverse reactions | 1486687 |
| sapropterin dihydrochloride | SAPROPTERIN DIHYDROCHLORIDE | NorthStar RxLLC | a64a50ba-e3da-4227-9bce-87101d60409e | 2025-01-06 | Warnings, Adverse reactions | 1486687 |
| JAVYGTOR | SAPROPTERIN DIHYDROCHLORIDE | Dr. Reddys Laboratories Inc | d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4 | 2024-10-21 | Warnings, Adverse reactions | 1486687 |
| Kuvan | SAPROPTERIN DIHYDROCHLORIDE | BioMarin Pharmaceutical Inc. | af38711e-8873-4790-a92d-4d583e23fb89 | 2024-08-26 | Warnings, Adverse reactions | 1486687 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| af38711e-8873-4790-a92d-4d583e23fb89 | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 79 | These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral use KUVAN (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 2007 | 20240826 |
| af38711e-8873-4790-a92d-4d583e23fb89 | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 79 | These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral use KUVAN (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 2007 | 20240826 |
| af38711e-8873-4790-a92d-4d583e23fb89 | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 79 | These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral use KUVAN (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 2007 | 20240826 |
| eafec3a2-4f29-4afa-8728-a62b34cefd18 | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 15 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS . SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20260417 |
| eafec3a2-4f29-4afa-8728-a62b34cefd18 | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 15 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS . SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20260417 |
| eafec3a2-4f29-4afa-8728-a62b34cefd18 | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 15 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS . SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20260417 |
| ec8ea96c-8ec1-4301-a85d-d59562e548ca | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 3 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20260224 |
| ec8ea96c-8ec1-4301-a85d-d59562e548ca | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 3 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20260224 |
| ec8ea96c-8ec1-4301-a85d-d59562e548ca | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 3 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20260224 |
| a64a50ba-e3da-4227-9bce-87101d60409e | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 3 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250106 |
| a64a50ba-e3da-4227-9bce-87101d60409e | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 3 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250106 |
| a64a50ba-e3da-4227-9bce-87101d60409e | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 3 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250106 |
| c4d92cce-e899-4f14-b19c-5e17f9922215 | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 2 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250731 |
| c4d92cce-e899-4f14-b19c-5e17f9922215 | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 2 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250731 |
| c4d92cce-e899-4f14-b19c-5e17f9922215 | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 2 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250731 |
| d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4 | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 2 | These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR TM (sapropterin dihydrochloride) tablets, for oral use. Initial U.S. Approval: 2007 | 20241021 |
| d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4 | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 2 | These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR TM (sapropterin dihydrochloride) tablets, for oral use. Initial U.S. Approval: 2007 | 20241021 |
| d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4 | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 2 | These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR TM (sapropterin dihydrochloride) tablets, for oral use. Initial U.S. Approval: 2007 | 20241021 |
| 11ee25bc-f501-4f9d-b63d-63b2eee0147e | sapropterin dihydrochloride 100 MG Oral Tablet | PSN | 1 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250610 |
| 11ee25bc-f501-4f9d-b63d-63b2eee0147e | sapropterin dihydrochloride 100 MG Oral Tablet | SCD | 1 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250610 |
| 11ee25bc-f501-4f9d-b63d-63b2eee0147e | sapropterin dihydrochloride 100 MG Soluble Tablet | SY | 1 | These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | 20250610 |