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United States · US · US:75854-701_229fe84b-2986-42f6-877c-17d9da08b12c

Dhivy

Orange BookUNIISPLATC N04BA

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

Identification

ManufacturerAvion Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN04BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7585470101
    100 TABLET in 1 BOTTLE (75854-701-01)

Annotations

UNII (FDA Substance ID)
MNX7R8C5VO
CARBIDOPA HYDRATE
RxCUI 2019
Orange Book
N214869
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MNX7R8C5VO",
    "rxcui": "2019",
    "inchikey": "QTAOMKOIBXZKND-PPHPATTJSA-N",
    "display_name": "CARBIDOPA HYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "39d79ade-8ee0-40ba-9fdd-13045b8ddbdf": {
      "match": "brand_token",
      "title": "DHIVY (CARBIDOPA LEVODOPA) TABLET [AVION PHARMACEUTICALS, LLC]",
      "spl_version": "13",
      "published_date": "2026-04-03"
    }
  },
  "productid": "75854-701_229fe84b-2986-42f6-877c-17d9da08b12c",
  "productndc": "75854-701",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214869",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG;100MG",
        "product_no": "001",
        "approval_date": "Nov 12, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA HYDRATE; LEVODOPA",
  "proprietary_name": "Dhivy",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA214869",
  "marketing_category": "NDA",
  "nonproprietary_name": "Carbidopa Levodopa",
  "start_marketing_date": "20220713",
  "active_numerator_strength": "25; 100"
}

Related drugs

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