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United States · US · US:43386-980_13400de7-964e-4752-836d-6d87e466b84b

Carbidopa

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4338698001
    100 TABLET in 1 BOTTLE (43386-980-01)

Annotations

Orange Book
A204763
AB
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": "43386-980_13400de7-964e-4752-836d-6d87e466b84b",
  "productndc": "43386-980",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204763",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 20, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA",
  "proprietary_name": "Carbidopa",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204763",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbidopa",
  "start_marketing_date": "20171020",
  "active_numerator_strength": "25"
}

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