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United States · US · US:71335-2881_bed689c9-83b6-4803-87fd-2e8eb8dff61b
Methimazole
Orange BookUNIISPLATC H03BB52
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeH03BB52
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117133528811100 TABLET in 1 BOTTLE (71335-2881-1)
Annotations
UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A040350
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": "71335-2881_bed689c9-83b6-4803-87fd-2e8eb8dff61b",
"productndc": "71335-2881",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040350",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Mar 29, 2000"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 29, 2000"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "20MG",
"product_no": "003",
"approval_date": "Jun 7, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METHIMAZOLE",
"proprietary_name": "Methimazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040350",
"marketing_category": "ANDA",
"nonproprietary_name": "methimazole",
"start_marketing_date": "20220314",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code H03BB52.
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