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United States · US · US:55154-2643_1eaa3310-3185-42fb-83f4-6e44b32f61c0

Carbidopa and Levodopa

Orange BookUNIISPLATC N04BA

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeN04BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515426430
    10 BLISTER PACK in 1 BAG (55154-2643-0) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
MNX7R8C5VO
CARBIDOPA HYDRATE
RxCUI 2019
Orange Book
A073589
AB
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": {
    "87ab55c9-203d-d595-3e3e-0e38f2f6d9c4": {
      "match": "brand_token",
      "title": "CARBIDOPA AND LEVODOPA TABLET [DR. REDDY'S LABORATORIES INC]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "55154-2643_1eaa3310-3185-42fb-83f4-6e44b32f61c0",
  "productndc": "55154-2643",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "073589",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "001",
        "approval_date": "Aug 28, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA HYDRATE; LEVODOPA",
  "proprietary_name": "Carbidopa and Levodopa",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA073589",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbidopa and Levodopa",
  "start_marketing_date": "20250224",
  "active_numerator_strength": "25; 100"
}

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