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United States · US · US:69238-1621_30339825-d8d3-4000-ad4d-edbbd76c4e25

metyrosine

Orange BookUNIISPLATC C02KB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeC02KB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6923816211
    100 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-1)
  • ndc11
    6923816213
    30 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-3)

Annotations

UNII (FDA Substance ID)
DOQ0J0TPF7
METYROSINE
RxCUI 266604
Orange Book
A213734
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "DOQ0J0TPF7",
    "rxcui": "266604",
    "inchikey": "NHTGHBARYWONDQ-JTQLQIEISA-N",
    "display_name": "METYROSINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "027f02b1-be49-4822-91a5-6cd66b56c0e1": {
      "match": "brand_token",
      "title": "METYROSINE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "7",
      "published_date": "2026-04-29"
    }
  },
  "productid": "69238-1621_30339825-d8d3-4000-ad4d-edbbd76c4e25",
  "productndc": "69238-1621",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213734",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METYROSINE",
  "proprietary_name": "metyrosine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213734",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metyrosine",
  "start_marketing_date": "20200724",
  "active_numerator_strength": "250"
}

Related drugs

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