carbidopa, levodopa and entacapone

Orange BookSPLATC N04BX

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN04BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6233279931
100 TABLET, FILM COATED in 1 BOTTLE (62332-799-31)
ndc11
6233279991
1000 TABLET, FILM COATED in 1 BOTTLE (62332-799-91)

Annotations

Orange Book

A218535

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": "62332-799_ec2d4d50-cf4e-48fe-abee-391925e18c3a",
  "productndc": "62332-799",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218535",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;200MG;50MG",
        "product_no": "001",
        "approval_date": "Feb 5, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18.75MG;200MG;75MG",
        "product_no": "002",
        "approval_date": "Feb 5, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;200MG;100MG",
        "product_no": "003",
        "approval_date": "Feb 5, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "31.25MG;200MG;125MG",
        "product_no": "004",
        "approval_date": "Feb 5, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "37.5MG;200MG;150MG",
        "product_no": "005",
        "approval_date": "Feb 5, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;200MG;200MG",
        "product_no": "006",
        "approval_date": "Feb 5, 2026"
      }
    ],
    "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": "ANDA218535",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carbidopa, levodopa and entacapone",
  "start_marketing_date": "20260212",
  "active_numerator_strength": "37.5; 200; 150"
}

Related drugs

Other records sharing ATC code N04BX.

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