Northera

Orange BookUNIISPLATC C01CA27

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

Identification

ManufacturerLundbeck Pharmaceuticals LLC

CountryUS (United States)

ATC codeC01CA27

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6738682119
90 CAPSULE in 1 BOTTLE (67386-821-19)

Annotations

UNII (FDA Substance ID)

J7A92W69L7

DROXIDOPA

RxCUI 1489913

Orange Book

N203202

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": {
    "2179f02c-48d7-48eb-8007-5ae43d8d16bc": {
      "match": "brand_token",
      "title": "NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK PHARMACEUTICALS LLC]",
      "spl_version": "26",
      "published_date": "2025-12-17"
    }
  },
  "productid": "67386-821_5e69b39c-3254-43bc-ae4d-258222a964d5",
  "productndc": "67386-821",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203202",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Feb 18, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Feb 18, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DROXIDOPA",
  "proprietary_name": "Northera",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA203202",
  "marketing_category": "NDA",
  "nonproprietary_name": "droxidopa",
  "start_marketing_date": "20140901",
  "active_numerator_strength": "200"
}

Related drugs

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