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United States · US · US:50090-6536_687184dc-0622-4b41-96c3-dbe2b4766b55

Methimazole

Orange BookUNIISPLATC H03BB52

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeH03BB52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009065360
    90 TABLET in 1 BOTTLE (50090-6536-0)

Annotations

UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A040734
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "554Z48XN5E",
    "rxcui": "6835",
    "inchikey": "PMRYVIKBURPHAH-UHFFFAOYSA-N",
    "display_name": "METHIMAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "06bb4bcc-5e47-48b6-a76c-648f846704e8": {
      "match": "brand_token",
      "title": "METHIMAZOLE TABLET [AIPING PHARMACEUTICAL, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-02"
    }
  },
  "productid": "50090-6536_687184dc-0622-4b41-96c3-dbe2b4766b55",
  "productndc": "50090-6536",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040734",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 14, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 14, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHIMAZOLE",
  "proprietary_name": "Methimazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040734",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methimazole",
  "start_marketing_date": "20120115",
  "active_numerator_strength": "5"
}

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