Methimazole

Orange BookUNIISPLATC H03BB52

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAiPing Pharmaceutical, Inc.

CountryUS (United States)

ATC codeH03BB52

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1178801201
100 TABLET in 1 BOTTLE (11788-012-01)

Annotations

UNII (FDA Substance ID)

554Z48XN5E

METHIMAZOLE

RxCUI 6835

Orange Book

A040547

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": "11788-012_6fdbe6c8-2389-42d3-982c-05174f494709",
  "productndc": "11788-012",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040547",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 18, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Feb 18, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHIMAZOLE",
  "proprietary_name": "Methimazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040547",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methimazole",
  "start_marketing_date": "20260401",
  "active_numerator_strength": "10"
}

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