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United States · US · US:33342-336_ea518c56-49d7-4770-8ded-21e443e71c3c
Methimazole
Orange BookUNIISPLATC H03BB52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeH03BB52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc113334233611100 TABLET in 1 BOTTLE (33342-336-11)
- ndc11333423361210 BLISTER PACK in 1 CARTON (33342-336-12) / 10 TABLET in 1 BLISTER PACK
- ndc1133342336441000 TABLET in 1 BOTTLE (33342-336-44)
Annotations
UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A209827
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": "33342-336_ea518c56-49d7-4770-8ded-21e443e71c3c",
"productndc": "33342-336",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209827",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "May 24, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "May 24, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHIMAZOLE",
"proprietary_name": "Methimazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209827",
"marketing_category": "ANDA",
"nonproprietary_name": "Methimazole",
"start_marketing_date": "20230524",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code H03BB52.
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