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United States · US · US:62756-457_91ce9c25-03a0-40d1-a463-60929a93114e

CARBIDOPA AND LEVODOPA

Orange BookSPLATC N04BA

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

Identification

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

Packs · 4

  • ndc11
    6275645708
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-457-08)
  • ndc11
    6275645718
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-457-18)
  • ndc11
    6275645783
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-457-83)
  • ndc11
    6275645788
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-457-88)

Annotations

Orange Book
A077828
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": "62756-457_91ce9c25-03a0-40d1-a463-60929a93114e",
  "productndc": "62756-457",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077828",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;100MG",
        "product_no": "001",
        "approval_date": "Aug 23, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG;200MG",
        "product_no": "002",
        "approval_date": "Aug 23, 2007"
      }
    ],
    "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": "ANDA077828",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBIDOPA AND LEVODOPA",
  "start_marketing_date": "20070823",
  "active_numerator_strength": "50; 200"
}

Related drugs

Other records sharing ATC code N04BA.

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