Cobenfy NDC 0003-1100

NDC codes

FDA NDC Directory

Product NDC (as listed)0003-1100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00003-1100Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0003-1100-14	00003110014	14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-1100-14)Marketed from Sep 27, 2024 · Sample package
0003-1100-60	00003110060	60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-1100-60)Marketed from Sep 27, 2024
0003-1100-98	00003110098	10 BLISTER PACK in 1 CARTON (0003-1100-98) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Jun 15, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Cobenfy
Generic name (nonproprietary): xanomeline and trospium chloride
Active ingredients: Xanomeline — 100 mg/1Trospium chloride — 20 mg/1
Dosage form: Capsule, Coated pellets
Route: Oral
Labeler: E.R. Squibb & Sons, L.L.C.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216158
Marketing start: Sep 27, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Agonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0003-1100_88ec22d3-785d-45e6-bda1-be532e75bcbcSPL ID 88ec22d3-785d-45e6-bda1-be532e75bcbcSPL set ID 8f0e73bf-6025-44f6-ab64-0983322de0dfRxCUI 2694843, 2694850, 2694853, 2694855, 2694989, 2694991, 2694992, 2694993, 2695671, 2695672UNII 1E6682427E, 9ORI6L73CJUPC 0300030050601, 0300030125606
Pharmacologic class: Cholinergic Muscarinic Agonist; Cholinergic Muscarinic Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400003110014 followed by a unit qualifier and the quantity

Package 00003-1100-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 16, 2026.

Indications (excerpt from the label)

COBENFY is indicated for the treatment of schizophrenia in adults. COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, indicated for the treatment of schizophrenia in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216158

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216158
Product	Strength	Form · route	Labeler	Product NDC
Cobenfyxanomeline and trospium chloride	—	Kit	E.R. Squibb & Sons, L.L.C.	0003-5200
Cobenfyxanomeline and trospium chloride	Xanomeline 50 mg/1; Trospium chloride 20 mg/1	Capsule, Coated pelletsOral	E.R. Squibb & Sons, L.L.C.	0003-0050
Cobenfyxanomeline and trospium chloride	Xanomeline 125 mg/1; Trospium chloride 30 mg/1	Capsule, Coated pelletsOral	E.R. Squibb & Sons, L.L.C.	0003-0125
Cobenfyxanomeline and trospium chloride	—	Kit	E.R. Squibb & Sons, L.L.C.	0003-5150