SAPROPTERIN DIHYDROCHLORIDE

{
  "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": "49884-873_d9caf600-36bf-443b-bd05-cfeef3d84522",
  "productndc": "49884-873",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210027",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG/PACKET",
        "product_no": "001",
        "approval_date": "Aug 20, 2019"
      }
    ],
    "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": "ANDA210027",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SAPROPTERIN DIHYDROCHLORIDE",
  "start_marketing_date": "20201001",
  "active_numerator_strength": "500"
}