Carbidopa and Levodopa

Orange BookSPLATC N04BA

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

Identification

ManufacturerCoupler LLC

CountryUS (United States)

ATC codeN04BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6704616143
30 TABLET in 1 BLISTER PACK (67046-1614-3)

Annotations

Orange Book

A216537

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "87ab55c9-203d-d595-3e3e-0e38f2f6d9c4": {
      "match": "brand_token",
      "title": "CARBIDOPA AND LEVODOPA TABLET [DR. REDDY'S LABORATORIES INC]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "67046-1614_43ce4d9e-fb3c-ed29-e063-6294a90a99ca",
  "productndc": "67046-1614",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216537",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;100MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;250MG",
        "product_no": "003",
        "approval_date": "Nov 28, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA; LEVODOPA",
  "proprietary_name": "Carbidopa and Levodopa",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA216537",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbidopa and Levodopa",
  "start_marketing_date": "20251117",
  "active_numerator_strength": "10; 100"
}

Related drugs

Other records sharing ATC code N04BA.

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