Carbidopa, Levodopa and Entacapone

Orange BookSPLATC N04BX

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN04BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3334249611
100 TABLET, FILM COATED in 1 BOTTLE (33342-496-11)
ndc11
3334249612
10 BLISTER PACK in 1 CARTON (33342-496-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

Orange Book

A214495

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": "33342-496_ab41796a-b051-41fa-b8ee-e88b9236931a",
  "productndc": "33342-496",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214495",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;200MG;50MG",
        "product_no": "001",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18.75MG;200MG;75MG",
        "product_no": "002",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;200MG;100MG",
        "product_no": "003",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "31.25MG;200MG;125MG",
        "product_no": "004",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG;200MG;150MG",
        "product_no": "005",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;200MG;200MG",
        "product_no": "006",
        "approval_date": "Apr 15, 2025"
      }
    ],
    "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": "ANDA214495",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbidopa, Levodopa and Entacapone",
  "start_marketing_date": "20250415",
  "active_numerator_strength": "50; 200; 200"
}

Related drugs

Other records sharing ATC code N04BX.

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