SINEMET

Orange BookSPLATC N04BA

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

Identification

ManufacturerOrganon LLC

CountryUS (United States)

ATC codeN04BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7820619001
100 TABLET in 1 BOTTLE (78206-190-01)

Annotations

Orange Book

N017555

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "9b17b028-964a-473c-823d-81423535bd66": {
      "match": "brand_token",
      "title": "SINEMET (CARBIDOPA AND LEVODOPA) TABLET [ORGANON LLC]",
      "spl_version": "5",
      "published_date": "2026-04-02"
    }
  },
  "productid": "78206-190_554f49ca-861e-4511-a54d-18c23d0ecbf7",
  "productndc": "78206-190",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017555",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG;100MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;250MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA; LEVODOPA",
  "proprietary_name": "SINEMET",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA017555",
  "marketing_category": "NDA",
  "nonproprietary_name": "carbidopa and levodopa",
  "start_marketing_date": "20250228",
  "active_numerator_strength": "25; 100"
}

Related drugs

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