🇺🇸
United States · US · US:69387-001_9ebcd7d7-1863-47e9-9c0d-2637d7f4f5af
BAFIERTAM
Orange BookUNIISPLATC L04AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBanner Life Sciences LLC
CountryUS (United States)
ATC codeL04AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116938700101120 CAPSULE in 1 BOTTLE (69387-001-01)
Annotations
UNII (FDA Substance ID)
45IUB1PX8R
MONOMETHYL FUMARATE
RxCUI 1546433
Orange Book
N210296
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "45IUB1PX8R",
"rxcui": "1546433",
"inchikey": "NKHAVTQWNUWKEO-NSCUHMNNSA-N",
"display_name": "MONOMETHYL FUMARATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a161f9d4-70f1-4097-957a-eafb35d3274f": {
"match": "brand_token",
"title": "BAFIERTAM (MONOMETHYL FUMARATE) CAPSULE [BANNER LIFE SCIENCES LLC\n]",
"spl_version": "10",
"published_date": "2025-11-17"
}
},
"productid": "69387-001_9ebcd7d7-1863-47e9-9c0d-2637d7f4f5af",
"productndc": "69387-001",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210296",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "95MG",
"product_no": "001",
"approval_date": "Apr 28, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MONOMETHYL FUMARATE",
"proprietary_name": "BAFIERTAM",
"active_ingred_unit": "mg/1",
"application_number": "NDA210296",
"marketing_category": "NDA",
"nonproprietary_name": "monomethyl fumarate",
"start_marketing_date": "20200428",
"active_numerator_strength": "95"
}Related drugs
Other records sharing ATC code L04AX.
Access this data programmatically
Query BAFIERTAM 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.