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United States · US · US:82804-231_e921f23b-a9bf-4313-9cfa-f0b29c06f72a
Methimazole
Orange BookUNIISPLATC H03BB52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeH03BB52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11828042313030 TABLET in 1 BOTTLE (82804-231-30)
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": "82804-231_e921f23b-a9bf-4313-9cfa-f0b29c06f72a",
"productndc": "82804-231",
"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": "10"
}Related drugs
Other records sharing ATC code H03BB52.
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