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United States · US · US:0259-6142_d7dccf06-ab71-4821-bda0-da271532a33d

Inbrija

Orange BookUNIISPLATC N04BA01

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

Identification

ManufacturerMerz Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN04BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0259614216
    4 BLISTER PACK in 1 CARTON (0259-6142-16) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01)
  • ndc11
    0259614232
    8 BLISTER PACK in 1 CARTON (0259-6142-32) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01)
  • ndc11
    0259614260
    15 BLISTER PACK in 1 CARTON (0259-6142-60) / 4 CAPSULE in 1 BLISTER PACK (0259-6142-01)

Annotations

UNII (FDA Substance ID)
46627O600J
LEVODOPA
RxCUI 6375
Orange Book
N209184
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "46627O600J",
    "rxcui": "6375",
    "inchikey": "WTDRDQBEARUVNC-LURJTMIESA-N",
    "display_name": "LEVODOPA",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "a906f8e1-6e1c-480a-8276-c01bc65dd3be": {
      "match": "brand_token",
      "title": "INBRIJA (LEVODOPA) CAPSULE [MERZ PHARMACEUTICALS, LLC]",
      "spl_version": "13",
      "published_date": "2026-01-23"
    }
  },
  "productid": "0259-6142_d7dccf06-ab71-4821-bda0-da271532a33d",
  "productndc": "0259-6142",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209184",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "42MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVODOPA",
  "proprietary_name": "Inbrija",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209184",
  "marketing_category": "NDA",
  "nonproprietary_name": "levodopa",
  "start_marketing_date": "20181222",
  "active_numerator_strength": "42"
}

Related drugs

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