Carbidopa

Orange BookSPL

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

Identification

ManufacturerEdenbridge Pharmaceuticals LLC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4279912301
100 TABLET in 1 BOTTLE (42799-123-01)

Annotations

Orange Book

A205304

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": "42799-123_462dd421-0006-e25d-e063-6294a90ad0ef",
  "productndc": "42799-123",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205304",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Feb 17, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA",
  "proprietary_name": "Carbidopa",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205304",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbidopa",
  "start_marketing_date": "20160219",
  "active_numerator_strength": "25"
}

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