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United States · US · US:64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7
Clemastine Fumarate
Orange BookUNIISPLATC R06AA54
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences
CountryUS (United States)
ATC codeR06AA54
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11649502680330 TABLET in 1 BOTTLE (64950-268-03)
- ndc116495026810100 TABLET in 1 BOTTLE (64950-268-10)
Annotations
UNII (FDA Substance ID)
19259EGQ3D
CLEMASTINE FUMARATE
RxCUI 142430
Orange Book
A073283
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "19259EGQ3D",
"rxcui": "142430",
"inchikey": "PMGQWSIVQFOFOQ-YKVZVUFRSA-N",
"display_name": "CLEMASTINE FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"60848a1b-f999-43d5-9df9-548f2f508401": {
"match": "brand_token",
"title": "CLEMASTINE FUMARATE POWDER [AX PHARMACEUTICAL CORP]",
"spl_version": "4",
"published_date": "2026-01-21"
}
},
"productid": "64950-268_813d92a9-7e67-455e-9158-6aa5af5b27a7",
"productndc": "64950-268",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "073283",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "2.68MG",
"product_no": "001",
"approval_date": "Jan 31, 1992"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLEMASTINE FUMARATE",
"proprietary_name": "Clemastine Fumarate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA073283",
"marketing_category": "ANDA",
"nonproprietary_name": "Clemastine Fumarate",
"start_marketing_date": "20241120",
"active_numerator_strength": "2.68"
}Related drugs
Other records sharing ATC code R06AA54.
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