🇺🇸
United States · US · US:59651-574_11ee25bc-f501-4f9d-b63d-63b2eee0147e
Sapropterin Dihydrochloride
Orange BookUNIISPLATC A16AX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA16AX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115965157408120 TABLET in 1 BOTTLE (59651-574-08)
- ndc115965157424240 TABLET in 1 BOTTLE (59651-574-24)
- ndc11596515743030 TABLET in 1 BOTTLE (59651-574-30)
Annotations
UNII (FDA Substance ID)
RG277LF5B3
SAPROPTERIN DIHYDROCHLORIDE
RxCUI 753341
Orange Book
A216797
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RG277LF5B3",
"rxcui": "753341",
"inchikey": "RKSUYBCOVNCALL-NTVURLEBSA-N",
"display_name": "SAPROPTERIN DIHYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6b2172e4-42fc-42fe-b1ad-9d6a974d4343": {
"match": "brand_token",
"title": "SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION [PAR HEALTH USA, LLC]",
"spl_version": "14",
"published_date": "2026-05-15"
}
},
"productid": "59651-574_11ee25bc-f501-4f9d-b63d-63b2eee0147e",
"productndc": "59651-574",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216797",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 9, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SAPROPTERIN DIHYDROCHLORIDE",
"proprietary_name": "Sapropterin Dihydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216797",
"marketing_category": "ANDA",
"nonproprietary_name": "Sapropterin Dihydrochloride",
"start_marketing_date": "20250609",
"active_numerator_strength": "100"
}Related drugs
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