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United States · US · US:63629-4134_ff612022-6924-42dc-b4cb-bb0d16c209f7

Carbidopa and Levodopa

Orange BookSPLATC N04BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN04BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6362941341
    30 TABLET in 1 BOTTLE (63629-4134-1)
  • ndc11
    6362941342
    270 TABLET in 1 BOTTLE (63629-4134-2)
  • ndc11
    6362941343
    60 TABLET in 1 BOTTLE (63629-4134-3)

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": "63629-4134_ff612022-6924-42dc-b4cb-bb0d16c209f7",
  "productndc": "63629-4134",
  "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": "20221128",
  "active_numerator_strength": "25; 250"
}

Related drugs

Other records sharing ATC code N04BA.

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