What is NDC 69238-2548?

69238-2548 is the product NDC for Tasimelteon, Tasimelteon 20 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tasimelteon NDC 69238-2548 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-2548Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-2548Add 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	Copy
69238-2548-3	69238254803	30 CAPSULE in 1 BOTTLE (69238-2548-3)Marketed from Feb 24, 2023

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: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211654
Marketing start: Feb 24, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 69238-2548_071804f4-9647-4a4d-a394-55b9e976dc9fSPL ID 071804f4-9647-4a4d-a394-55b9e976dc9fSPL set ID 99cb1928-e57d-4d04-87a1-38108780598aRxCUI 1490473UNII SHS4PU80D9UPC 0369238254839
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

N469238254803 followed by a unit qualifier and the quantity

Package 69238-2548-03. 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

Current FDA label (SPL), effective Jan 24, 2023.

Indications (excerpt from the label)

Tasimelteon capsule is a melatonin receptor agonist. Tasimelteon capsules are indicated for the treatment of Non 24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) Tasimelteon capsules are indicated for the treatment of Non-24-Hour in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-2548

What is NDC 69238-2548?: 69238-2548 is the product NDC for Tasimelteon, Tasimelteon 20 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, 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?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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?: 1 other product NDC 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tasimelteon	Tasimelteon 20 mg/1	CapsuleOral	Apotex Corp.	60505-4665	60505-4665-0360505-4665-09