CARBIDOPA, LEVODOPA AND ENTACAPONE

Orange BookSPLATC N04BX

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

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeN04BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1657168901
100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01)

Annotations

Orange Book

A213212

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": "16571-689_4d1e7e53-059c-4a41-86b0-66d20ce660d0",
  "productndc": "16571-689",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213212",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;200MG;50MG",
        "product_no": "001",
        "approval_date": "Jan 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18.75MG;200MG;75MG",
        "product_no": "002",
        "approval_date": "Jan 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;200MG;100MG",
        "product_no": "003",
        "approval_date": "Jan 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "31.25MG;200MG;125MG",
        "product_no": "004",
        "approval_date": "Jan 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG;200MG;150MG",
        "product_no": "005",
        "approval_date": "Jan 25, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;200MG;200MG",
        "product_no": "006",
        "approval_date": "Jan 25, 2022"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA213212",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBIDOPA, LEVODOPA AND ENTACAPONE",
  "start_marketing_date": "20210805",
  "active_numerator_strength": "12.5; 200; 50"
}

Related drugs

Other records sharing ATC code N04BX.

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