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United States · US · US:51079-923_3a39bb13-44d1-2652-e063-6294a90ad211

Carbidopa and Levodopa

Orange BookSPLATC N04BA

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

Identification

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

Packs · 1

  • ndc11
    5107992320
    100 BLISTER PACK in 1 CARTON (51079-923-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-923-01)

Annotations

Orange Book
A075091
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": "51079-923_3a39bb13-44d1-2652-e063-6294a90ad211",
  "productndc": "51079-923",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075091",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;200MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "002",
        "approval_date": "Apr 21, 2000"
      }
    ],
    "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": "ANDA075091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carbidopa and levodopa",
  "start_marketing_date": "19991201",
  "active_numerator_strength": "50; 200"
}

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