NDC codes

FDA NDC Directory
Product NDC (as listed)0003-5150Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00003-5150Add 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 NDC11-digit (billing)PackageCopy
0003-5150-14000035150141 KIT in 1 CARTON (0003-5150-14) * 1 BLISTER PACK in 1 PACKAGE (0003-0050-00) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK * 1 BLISTER PACK in 1 PACKAGE (0003-1100-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Sep 27, 2024 · Sample package

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
Dosage form
Kit
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 216158
Marketing start
Listing expires
Identifiers
Product ID 0003-5150_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

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400003515014 followed by a unit qualifier and the quantity

Package 00003-5150-14. 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.

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
ProductStrengthForm · routeLabelerProduct NDC
Cobenfyxanomeline and trospium chlorideXanomeline 100 mg/1; Trospium chloride 20 mg/1Capsule, Coated pelletsOralE.R. Squibb & Sons, L.L.C.0003-1100
Cobenfyxanomeline and trospium chloride—KitE.R. Squibb & Sons, L.L.C.0003-5200
Cobenfyxanomeline and trospium chlorideXanomeline 50 mg/1; Trospium chloride 20 mg/1Capsule, Coated pelletsOralE.R. Squibb & Sons, L.L.C.0003-0050
Cobenfyxanomeline and trospium chlorideXanomeline 125 mg/1; Trospium chloride 30 mg/1Capsule, Coated pelletsOralE.R. Squibb & Sons, L.L.C.0003-0125

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