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United States · US · US:70436-141_1af8aeac-14cf-4330-bf4e-3e50348268c1

droxidopa

Orange BookUNIISPLATC C01CA27

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

Identification

ManufacturerSlate Run Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC01CA27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7043614106
    90 CAPSULE in 1 BOTTLE (70436-141-06)

Annotations

UNII (FDA Substance ID)
J7A92W69L7
DROXIDOPA
RxCUI 1489913
Orange Book
A215265
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J7A92W69L7",
    "rxcui": "1489913",
    "inchikey": "QXWYKJLNLSIPIN-JGVFFNPUSA-N",
    "display_name": "DROXIDOPA",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d": {
      "match": "brand_token",
      "title": "DROXIDOPA CAPSULE [NOVADOZ PHARMACEUTICALS LLC]",
      "spl_version": "2",
      "published_date": "2026-02-10"
    }
  },
  "productid": "70436-141_1af8aeac-14cf-4330-bf4e-3e50348268c1",
  "productndc": "70436-141",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215265",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Nov 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Nov 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Nov 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DROXIDOPA",
  "proprietary_name": "droxidopa",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215265",
  "marketing_category": "ANDA",
  "nonproprietary_name": "droxidopa",
  "start_marketing_date": "20211110",
  "active_numerator_strength": "200"
}

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