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United States · US · US:50268-496_41168239-a16a-40e0-e063-6294a90a5c58
Methimazole
Orange BookUNIISPLATC H03BB52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeH03BB52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502684961550 BLISTER PACK in 1 BOX (50268-496-15) / 1 TABLET in 1 BLISTER PACK (50268-496-11)
Annotations
UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A218149
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": "50268-496_41168239-a16a-40e0-e063-6294a90a5c58",
"productndc": "50268-496",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218149",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Sep 25, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Sep 25, 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": "ANDA218149",
"marketing_category": "ANDA",
"nonproprietary_name": "methimazole",
"start_marketing_date": "20251013",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code H03BB52.
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