Prescription drug · NDA
Cobenfy (Xanomeline and trospium chloride) NDC 0003-0125
Xanomeline 125 mg/1; Trospium chloride 30 mg/1 · Capsule, Coated pellets · Oral · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-0125-14 | 0000301251400003012514 | 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0003-0125-14)Marketed from Sep 27, 2024 · Sample package | |
| 0003-0125-60 | 0000301256000003012560 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0003-0125-60)Marketed from Sep 27, 2024 | |
| 0003-0125-98 | 0000301259800003012598 | 10 BLISTER PACK in 1 CARTON (0003-0125-98) / 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 — 125 mg/1Trospium chloride — 30 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216158
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Agonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0003-0125_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 9ORI6L73CJ, 1E6682427EUPC 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
N400003012514followed by a unit qualifier and the quantityPackage 00003-0125-14. 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 .
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.
About NDC 0003-0125
- What is NDC 0003-0125?
- 0003-0125 is the product NDC for Cobenfy, Xanomeline 125 mg/1; Trospium chloride 30 mg/1 capsule, coated pellets, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cobenfy (Xanomeline and trospium chloride).
- What is the active ingredient?
- Xanomeline, Trospium chloride.
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cobenfy?
- 4 other product NDCs are listed under this name. See all Cobenfy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cobenfy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 | 00003-0050-1400003-0050-6000003-0050-98 |
| Cobenfyxanomeline and trospium chloride | Xanomeline 100 mg/1; Trospium chloride 20 mg/1 | Capsule, Coated pelletsOral | E.R. Squibb & Sons, L.L.C. | 0003-1100 | 00003-1100-1400003-1100-6000003-1100-98 |
| Cobenfyxanomeline and trospium chloride | — | Kit | E.R. Squibb & Sons, L.L.C. | 0003-5150 | 00003-5150-14 |
| Cobenfyxanomeline and trospium chloride | — | Kit | E.R. Squibb & Sons, L.L.C. | 0003-5200 | 00003-5200-56 |
Other NDCs under NDA 216158
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 100 mg/1; Trospium chloride 20 mg/1 | Capsule, Coated pelletsOral | E.R. Squibb & Sons, L.L.C. | 0003-1100 |
| Cobenfyxanomeline and trospium chloride | — | Kit | E.R. Squibb & Sons, L.L.C. | 0003-5150 |
| Cobenfyxanomeline and trospium chloride | — | Kit | E.R. Squibb & Sons, L.L.C. | 0003-5200 |