NDC codes

FDA NDC Directory
Product NDC (as listed)60505-4665Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-4665Add 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
60505-4665-3605054665036050546650330 CAPSULE in 1 BOTTLE (60505-4665-3)Marketed from Jan 5, 2024
60505-4665-9605054665096050546650990 CAPSULE in 1 BOTTLE (60505-4665-9)Marketed from Jan 5, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Tasimelteon
Generic name (nonproprietary)
tasimelteon
Active ingredients
Tasimelteon — 20 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211607
Marketing start
Listing expires
Other FDA classes
Melatonin Receptor Agonists (Mechanism)
Identifiers
Product ID 60505-4665_6920d3c7-5e2f-1303-d9dd-85d7c1dfba8dSPL ID 6920d3c7-5e2f-1303-d9dd-85d7c1dfba8d
Pharmacologic class
Melatonin Receptor Agonist

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

N460505466503 followed by a unit qualifier and the quantity

Package 60505-4665-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-4665

What is NDC 60505-4665?
60505-4665 is the product NDC for Tasimelteon, Tasimelteon 20 mg/1 capsule, listed with the FDA by Apotex Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tasimelteon.
What is the active ingredient?
Tasimelteon.
Who is the labeler?
Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tasimelteon?
2 other product NDCs are listed under this name. See all Tasimelteon NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tasimelteon NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TasimelteonTasimelteon 20 mg/1CapsuleOralAmneal Pharmaceuticals NY LLC69238-254869238-2548-03
TasimelteonTasimelteon 20 mg/1Capsule, Gelatin coatedOralTeva Pharmaceuticals, Inc.0480-449000480-4490-56

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