FDA.reportPublic FDA data

Cobenfy

Product NDC
0003-0050
11-digit product format
000030050
Labeler code
0003
Product ID
0003-0050_51277f95-1b88-42b7-9e2b-7a0bfd609ccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
xanomeline and trospium chloride
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
Application
NDA216158
Marketing category
NDA
Marketing start
2024-09-27
Substance
TROSPIUM CHLORIDE; XANOMELINE
Active strength
20; 50 mg/1; mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cobenfy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROSPIUM CHLORIDE20 mg/1
XANOMELINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9ORI6L73CJ, 1E6682427E
Rxcui2694843, 2694850, 2694853, 2694855, 2694989, 2694991, 2694992, 2694993, 2695671, 2695672

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bfc41181-d174-476d-8a52-4a385ae9213dProduct name120250423
7c473500-2ad1-88f9-e10e-6f8136eda28cProduct name420250226
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0003-0050-00Cobenfy1 in 1 PACKAGECAPSULE, COATED PELLETS20 mg4
0003-0050-00Cobenfy4 in 1 BLISTER PACKCAPSULE, COATED PELLETS420 mg4
0003-0050-04Cobenfy4 in 1 BLISTER PACKCAPSULE, COATED PELLETS420 mg4
0003-0050-04Cobenfy1 in 1 PACKAGECAPSULE, COATED PELLETS50 mg4
0003-0050-14Cobenfy14 in 1 BLISTER PACKCAPSULE, COATED PELLETS144
0003-0050-60Cobenfy60 in 1 BOTTLECAPSULE, COATED PELLETS604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-0050-60EA - Each0003-00509411c897-75d5-4fac-b94b-97bfae82115012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-0050COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) CAPSULE, COATED PELLETS COBENFY (XANOMELINE AND TROSPIUM CHLORIDE) KIT [E.R. SQUIBB & SONS, L.L.C.]3Current NDC, 2 package rows20241019_8f0e73bf-6025-44f6-ab64-0983322de0df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695672{10 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule [Cobenfy]) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]) } Pack [Cobenfy 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 Count]BPCK8f0e73bf-6025-44f6-ab64-0983322de0df4
2694993{52 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule [Cobenfy]) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]) } Pack [Cobenfy 28-Day Starter Kit]BPCK8f0e73bf-6025-44f6-ab64-0983322de0df4
2695671{10 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule) } PackGPCK8f0e73bf-6025-44f6-ab64-0983322de0df4
2694992{52 (trospium chloride 20 MG / xanomeline 100 MG Oral Capsule) / 4 (trospium chloride 20 MG / xanomeline 50 MG Oral Capsule) } PackGPCK8f0e73bf-6025-44f6-ab64-0983322de0df4
2694991COBENFY 100 MG / 20 MG Oral CapsulePSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694855COBENFY 125 MG / 30 MG Oral CapsulePSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694993COBENFY 28-Day Starter Kit 56 CountPSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694850COBENFY 50 MG / 20 MG Oral CapsulePSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2695672COBENFY 7-Day Titration Pack 14 CountPSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694989xanomeline 100 MG / trospium chloride 20 MG Oral CapsulePSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694853xanomeline 125 MG / trospium chloride 30 MG Oral CapsulePSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694843xanomeline 50 MG / trospium chloride 20 MG Oral CapsulePSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694992xanomeline/trospium chloride 28-Day Starter Kit 56 CountPSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2695671xanomeline/trospium chloride 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 CountPSN8f0e73bf-6025-44f6-ab64-0983322de0df4
2694991trospium chloride 20 MG / xanomeline 100 MG Oral Capsule [Cobenfy]SBD8f0e73bf-6025-44f6-ab64-0983322de0df4
2694850trospium chloride 20 MG / xanomeline 50 MG Oral Capsule [Cobenfy]SBD8f0e73bf-6025-44f6-ab64-0983322de0df4
2694855trospium chloride 30 MG / xanomeline 125 MG Oral Capsule [Cobenfy]SBD8f0e73bf-6025-44f6-ab64-0983322de0df4
2694989trospium chloride 20 MG / xanomeline 100 MG Oral CapsuleSCD8f0e73bf-6025-44f6-ab64-0983322de0df4
2694843trospium chloride 20 MG / xanomeline 50 MG Oral CapsuleSCD8f0e73bf-6025-44f6-ab64-0983322de0df4
2694853trospium chloride 30 MG / xanomeline 125 MG Oral CapsuleSCD8f0e73bf-6025-44f6-ab64-0983322de0df4
2694991Cobenfy (trospium chloride 20 MG / xanomeline 100 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694850Cobenfy (trospium chloride 20 MG / xanomeline 50 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694855Cobenfy (trospium chloride 30 MG / xanomeline 125 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694991Cobenfy 100 MG / 20 MG (equivalent to xanomeline tartrate 153.3 MG / trospium 18.3 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694855Cobenfy 125 MG / 30 MG (equivalent to xanomeline tartrate 191.7 MG / trospium 27.5 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694993Cobenfy 28-Day (50 MG/20 MG (4), 100 MG/20 MG (52)) Starter KitSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694850Cobenfy 50 MG / 20 MG (equivalent to xanomeline tartrate 76.7 MG / trospium 18.3 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2695672Cobenfy 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 CountSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694989xanomeline 100 MG (equivalent to xanomeline tartrate 153.3 MG) / trospium chloride 20 MG (equivalent to trospium 18.3 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694853xanomeline 125 MG (equivalent to xanomeline tartrate 191.7 MG) / trospium chloride 30 MG (equivalent to trospium 27.5 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694843xanomeline 50 MG (equivalent to xanomeline tartrate 76.7 MG) / trospium chloride 20 MG (trospium 18.3 MG) Oral CapsuleSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2694992xanomeline/trospium chloride 28-Day (50 MG/20 MG (4), 100 MG/20 MG (52)) Starter KitSY8f0e73bf-6025-44f6-ab64-0983322de0df4
2695671xanomeline/trospium chloride 7-Day Titration Pack - 50 MG/20 MG (4), 100 MG/20 MG (10) 14 CountSY8f0e73bf-6025-44f6-ab64-0983322de0df4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0003-0050-00000030050001 in 1 PACKAGEHistorical
0003-0050-04000030050044 in 1 BLISTER PACKHistorical
0003-0050-140000300501414 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0050-14) 2024-09-27YesNoHistorical
0003-0050-600000300506060 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0050-60) 2024-09-27NoNoHistorical