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United States · US · US:0003-5200_51277f95-1b88-42b7-9e2b-7a0bfd609ccf
Cobenfy
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerE.R. Squibb & Sons, L.L.C.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100035200561 KIT in 1 CARTON (0003-5200-56) * 1 BLISTER PACK in 1 PACKAGE (0003-0050-04) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE (0003-1100-01) / 52 CAPSULE, COATED PELLETS in 1 BLISTER PACK
Annotations
Orange Book
N216158
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"8f0e73bf-6025-44f6-ab64-0983322de0df": {
"match": "brand_token",
"title": "COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) CAPSULE, COATED PELLETS COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) KIT [E.R. SQUIBB & SONS, L.L.C.]",
"spl_version": "4",
"published_date": "2026-01-30"
}
},
"productid": "0003-5200_51277f95-1b88-42b7-9e2b-7a0bfd609ccf",
"productndc": "0003-5200",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "216158",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG;EQ 50MG BASE",
"product_no": "001",
"approval_date": "Sep 26, 2024"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG;EQ 100MG BASE",
"product_no": "002",
"approval_date": "Sep 26, 2024"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "30MG;EQ 125MG BASE",
"product_no": "003",
"approval_date": "Sep 26, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Cobenfy",
"active_ingred_unit": null,
"application_number": "NDA216158",
"marketing_category": "NDA",
"nonproprietary_name": "xanomeline and trospium chloride",
"start_marketing_date": "20240927",
"active_numerator_strength": null
}Access this data programmatically
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