🇺🇸
United States · US · US:62135-713_ffe63870-181f-e007-e053-6294a90a074e
CLEMASTINE FUMARATE
Orange BookUNIISPLATC R06AA54
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeR06AA54
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116213571341120 mL in 1 BOTTLE (62135-713-41)
Annotations
UNII (FDA Substance ID)
19259EGQ3D
CLEMASTINE FUMARATE
RxCUI 142430
Orange Book
A074884
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": "62135-713_ffe63870-181f-e007-e053-6294a90a074e",
"productndc": "62135-713",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "074884",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "EQ 0.5MG BASE/5ML",
"product_no": "001",
"approval_date": "Dec 17, 1997"
}
],
"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": "ANDA074884",
"marketing_category": "ANDA",
"nonproprietary_name": "CLEMASTINE FUMARATE",
"start_marketing_date": "19971217",
"active_numerator_strength": ".67"
}Related drugs
Other records sharing ATC code R06AA54.
Access this data programmatically
Query CLEMASTINE FUMARATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.