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United States · US · US:68788-8226_8151209d-8832-4a7b-8b4c-cc32c62ffeea

Methimazole

Orange BookUNIISPLATC H03BB52

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeH03BB52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6878882263
    30 TABLET in 1 BOTTLE (68788-8226-3)
  • ndc11
    6878882266
    60 TABLET in 1 BOTTLE (68788-8226-6)

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": "68788-8226_8151209d-8832-4a7b-8b4c-cc32c62ffeea",
  "productndc": "68788-8226",
  "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": "20220808",
  "active_numerator_strength": "5"
}

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