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United States · US · US:64980-572_807ace4b-b2af-44b4-9371-884d73e21601

Methyldopa

Orange BookUNIISPLATC C02AB01

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeC02AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6498057201
    100 TABLET in 1 BOTTLE (64980-572-01)

Annotations

UNII (FDA Substance ID)
56LH93261Y
METHYLDOPA
RxCUI 6876
Orange Book
A070076
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "56LH93261Y",
    "rxcui": "6876",
    "inchikey": "YKFCISHFRZHKHY-NGQGLHOPSA-N",
    "display_name": "METHYLDOPA",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9e22e1d8-04ec-4b67-92ea-b09c706f2703": {
      "match": "brand_token",
      "title": "METHYLDOPA TABLET [RISING PHARMA HOLDINGS, INC.]",
      "spl_version": "3",
      "published_date": "2025-04-07"
    }
  },
  "productid": "64980-572_807ace4b-b2af-44b4-9371-884d73e21601",
  "productndc": "64980-572",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070076",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 18, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Apr 18, 1985"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLDOPA",
  "proprietary_name": "Methyldopa",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070076",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methyldopa",
  "start_marketing_date": "20240916",
  "active_numerator_strength": "500"
}

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