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United States · US · US:71085-081_3b2a232e-e840-b8e1-e063-6394a90ae51d
CLEMSZA
Orange BookUNIISPLATC R06AA54
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIPG Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AA54
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11710850813030 TABLET in 1 BOTTLE (71085-081-30)
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": {
"9a35ed77-e35c-4c54-ad7f-1b92e450fa20": {
"match": "brand_token",
"title": "CLEMSZA (CLEMASTINE FUMARATE) TABLET [IPG PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2025-08-04"
}
},
"productid": "71085-081_3b2a232e-e840-b8e1-e063-6394a90ae51d",
"productndc": "71085-081",
"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": "CLEMSZA",
"active_ingred_unit": "mg/1",
"application_number": "ANDA073283",
"marketing_category": "ANDA",
"nonproprietary_name": "Clemastine Fumarate",
"start_marketing_date": "20250801",
"active_numerator_strength": "2.68"
}Related drugs
Other records sharing ATC code R06AA54.
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