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United States · US · US:0781-5641_2176ea25-da6b-47b2-a081-b3da614df0a0

Carbidopa, Levodopa, and Entacapone

Orange BookSPLATC N04BX

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN04BX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781564101
    100 TABLET, FILM COATED in 1 BOTTLE (0781-5641-01)

Annotations

Orange Book
N021485
ABABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "f0d9d7a8-1d06-4119-b2bc-42b3ec08d45b": {
      "match": "brand_token",
      "title": "CARBIDOPA, LEVODOPA AND ENTACAPONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "0781-5641_2176ea25-da6b-47b2-a081-b3da614df0a0",
  "productndc": "0781-5641",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021485",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG;200MG;50MG",
        "product_no": "001",
        "approval_date": "Jun 11, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG;200MG;100MG",
        "product_no": "002",
        "approval_date": "Jun 11, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "37.5MG;200MG;150MG",
        "product_no": "003",
        "approval_date": "Jun 11, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG;200MG;200MG",
        "product_no": "004",
        "approval_date": "Aug 2, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "18.75MG;200MG;75MG",
        "product_no": "005",
        "approval_date": "Aug 29, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "31.25MG;200MG;125MG",
        "product_no": "006",
        "approval_date": "Aug 29, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA; ENTACAPONE; LEVODOPA",
  "proprietary_name": "Carbidopa, Levodopa, and Entacapone",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA021485",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Carbidopa, Levodopa, and Entacapone",
  "start_marketing_date": "20140618",
  "active_numerator_strength": "31.25; 200; 125"
}

Related drugs

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