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United States · US · US:47335-186_5c297458-6e97-4222-8a82-1b28928ce796

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
    4733518608
    100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-08)
  • ndc11
    4733518618
    1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-18)
  • ndc11
    4733518683
    30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-83)
  • ndc11
    4733518688
    100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47335-186-88)

Annotations

Orange Book
A078690
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": "47335-186_5c297458-6e97-4222-8a82-1b28928ce796",
  "productndc": "47335-186",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "078690",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG;100MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "002",
        "approval_date": "Jul 31, 2009"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;250MG",
        "product_no": "003",
        "approval_date": "Jul 31, 2009"
      }
    ],
    "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": "ANDA078690",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBIDOPA AND LEVODOPA",
  "start_marketing_date": "20141215",
  "active_numerator_strength": "10; 100"
}

Related drugs

Other records sharing ATC code N04BA.

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