Carbidopa and Levodopa

Orange BookSPLATC N04BA

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN04BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071021421
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-2142-1)

Annotations

Orange Book

N203312

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": "70710-2142_9f66a828-7712-41a2-8380-682a3bbe50d6",
  "productndc": "70710-2142",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203312",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "23.75MG;95MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "36.25MG;145MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "48.75MG;195MG",
        "product_no": "003",
        "approval_date": "Jan 7, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "61.25MG;245MG",
        "product_no": "004",
        "approval_date": "Jan 7, 2015"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA203312",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Carbidopa and Levodopa",
  "start_marketing_date": "20251020",
  "active_numerator_strength": "61.25; 245"
}

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