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United States · US · US:48433-015_4d642d35-3931-745e-e063-6294a90a8e63

Carbidopa and Levodopa

Orange BookUNIISPLATC N04BA

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

Identification

ManufacturerSafecor Health, LLC
CountryUS (United States)
ATC codeN04BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4843301520
    100 BLISTER PACK in 1 CARTON (48433-015-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (48433-015-01)

Annotations

UNII (FDA Substance ID)
MNX7R8C5VO
CARBIDOPA HYDRATE
RxCUI 2019
Orange Book
A075091
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MNX7R8C5VO",
    "rxcui": "2019",
    "inchikey": "QTAOMKOIBXZKND-PPHPATTJSA-N",
    "display_name": "CARBIDOPA HYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "48433-015_4d642d35-3931-745e-e063-6294a90a8e63",
  "productndc": "48433-015",
  "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 HYDRATE; 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": "20260313",
  "active_numerator_strength": "25; 100"
}

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