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United States · US · US:16729-079_40a9fe53-d24b-d4ad-e063-6294a90aeff5

CARBIDOPA AND LEVODOPA

Orange BookSPLATC N04BA

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

Identification

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

Packs · 2

  • ndc11
    1672907901
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-079-01)
  • ndc11
    1672907917
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-079-17)

Annotations

Orange Book
A202323
ABAB
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": "16729-079_40a9fe53-d24b-d4ad-e063-6294a90aeff5",
  "productndc": "16729-079",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "202323",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "001",
        "approval_date": "Feb 8, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;200MG",
        "product_no": "002",
        "approval_date": "Feb 8, 2013"
      }
    ],
    "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": "ANDA202323",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbidopa and Levodopa",
  "start_marketing_date": "20130613",
  "active_numerator_strength": "50; 200"
}

Related drugs

Other records sharing ATC code N04BA.

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