Sapropterin Dihydrochloride

Orange BookUNIISPLATC A16AX07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeA16AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4257150941
30 PACKET in 1 CARTON (42571-509-41) / 1 POWDER, FOR SOLUTION in 1 PACKET (42571-509-30)

Annotations

UNII (FDA Substance ID)

RG277LF5B3

SAPROPTERIN DIHYDROCHLORIDE

RxCUI 753341

Orange Book

A219511

ABAB

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": "42571-509_4853076d-14bd-87db-e063-6294a90aad9e",
  "productndc": "42571-509",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "219511",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG/PACKET",
        "product_no": "001",
        "approval_date": "Jan 8, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG/PACKET",
        "product_no": "002",
        "approval_date": "Jan 8, 2026"
      }
    ],
    "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": "ANDA219511",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sapropterin Dihydrochloride",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "100"
}

Related drugs

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