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United States · US · US:64950-324_1c00b77a-2510-443b-9ecc-dc6f953b50b0
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 · 1
- ndc116495032412120 mL in 1 BOTTLE (64950-324-12)
Annotations
UNII (FDA Substance ID)
19259EGQ3D
CLEMASTINE FUMARATE
RxCUI 142430
Orange Book
A073399
AA
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": "64950-324_1c00b77a-2510-443b-9ecc-dc6f953b50b0",
"productndc": "64950-324",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "073399",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "EQ 0.5MG BASE/5ML",
"product_no": "001",
"approval_date": "Jun 30, 1994"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLEMASTINE FUMARATE",
"proprietary_name": "Clemastine Fumarate",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA073399",
"marketing_category": "ANDA",
"nonproprietary_name": "Clemastine Fumarate",
"start_marketing_date": "20241122",
"active_numerator_strength": ".67"
}Related drugs
Other records sharing ATC code R06AA54.
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