cobenfy

Generic: xanomeline and trospium chloride

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cobenfy
Generic Name xanomeline and trospium chloride
Labeler e.r. squibb & sons, l.l.c.
Dosage Form KIT
Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-5200
Product ID 0003-5200_51277f95-1b88-42b7-9e2b-7a0bfd609ccf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216158
Listing Expiration 2027-12-31
Marketing Start 2024-09-27

Pharmacologic Class

Established (EPC)
cholinergic muscarinic agonist [epc]
Mechanism of Action
cholinergic muscarinic agonists [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00035200
Hyphenated Format 0003-5200

Supplemental Identifiers

RxCUI
2694843 2694850 2694853 2694855 2694989 2694991 2694992 2694993 2695671 2695672
UPC
0300030050601 0300030125606
UNII
9ORI6L73CJ 1E6682427E
NUI
N0000175840 N0000000104 N0000182141 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cobenfy (source: ndc)
Generic Name xanomeline and trospium chloride (source: ndc)
Application Number NDA216158 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 50 mg/20 mg
  • 20 mg
  • 100 mg/20 mg
  • 125 mg/30 mg
  • 30 mg
source: label
Packaging
  • 1 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
source: ndc

Packages (1)

0003-5200-56 1 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cobenfy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "51277f95-1b88-42b7-9e2b-7a0bfd609ccf", "openfda": {"nui": ["N0000175840", "N0000000104", "N0000182141", "N0000185503"], "upc": ["0300030050601", "0300030125606"], "unii": ["9ORI6L73CJ", "1E6682427E"], "rxcui": ["2694843", "2694850", "2694853", "2694855", "2694989", "2694991", "2694992", "2694993", "2695671", "2695672"], "spl_set_id": ["8f0e73bf-6025-44f6-ab64-0983322de0df"], "pharm_class_epc": ["Cholinergic Muscarinic Agonist [EPC]"], "pharm_class_moa": ["Cholinergic Muscarinic Agonists [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 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", "package_ndc": "0003-5200-56", "marketing_start_date": "20240927"}], "brand_name": "Cobenfy", "product_id": "0003-5200_51277f95-1b88-42b7-9e2b-7a0bfd609ccf", "dosage_form": "KIT", "product_ndc": "0003-5200", "generic_name": "xanomeline and trospium chloride", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cobenfy", "application_number": "NDA216158", "marketing_category": "NDA", "marketing_start_date": "20240927", "listing_expiration_date": "20271231"}