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United States · US · US:67046-1651_490f045d-bcd2-3eb2-e063-6294a90a6d59
methimazole
Orange BookUNIISPLATC H03BB52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeH03BB52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461651330 TABLET in 1 BLISTER PACK (67046-1651-3)
Annotations
UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A218830
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": "67046-1651_490f045d-bcd2-3eb2-e063-6294a90a6d59",
"productndc": "67046-1651",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218830",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 5, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Feb 5, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHIMAZOLE",
"proprietary_name": "methimazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218830",
"marketing_category": "ANDA",
"nonproprietary_name": "methimazole",
"start_marketing_date": "20260123",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code H03BB52.
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