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United States · US · US:64980-264_2ac7fbad-6a1b-4326-9339-b2b3139ce554

Methimazole

Orange BookUNIISPLATC H03BB52

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeH03BB52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6498026401
    100 TABLET in 1 BOTTLE (64980-264-01)

Annotations

UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A202068
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": "64980-264_2ac7fbad-6a1b-4326-9339-b2b3139ce554",
  "productndc": "64980-264",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202068",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 7, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 7, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHIMAZOLE",
  "proprietary_name": "Methimazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202068",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methimazole",
  "start_marketing_date": "20210422",
  "active_numerator_strength": "5"
}

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