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United States · US · US:16571-157_bf8b1cec-9b24-4102-b948-08c988bfca91

Carbidopa and Levodopa

Orange BookSPLATC N04BA

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN04BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1657115701
    100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (16571-157-01)

Annotations

Orange Book
A078893
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": "16571-157_bf8b1cec-9b24-4102-b948-08c988bfca91",
  "productndc": "16571-157",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "078893",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;100MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "002",
        "approval_date": "Sep 18, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;250MG",
        "product_no": "003",
        "approval_date": "Sep 18, 2008"
      }
    ],
    "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": "ANDA078893",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carbidopa and levodopa",
  "start_marketing_date": "20250108",
  "active_numerator_strength": "10; 100"
}

Related drugs

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