Rozerem (ramelteon) NDC 64764-805

NDC codes

FDA NDC Directory

Product NDC (as listed)64764-805Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64764-0805Add 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
64764-805-10	64764080510	100 TABLET, FILM COATED in 1 BOTTLE (64764-805-10)Marketed from Jul 22, 2005
64764-805-30	64764080530	30 TABLET, FILM COATED in 1 BOTTLE (64764-805-30)Marketed from Jul 22, 2005

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Rozerem
Generic name (nonproprietary): ramelteon
Active ingredients: Ramelteon — 8 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021782
Marketing start: Jul 22, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 64764-805_2021e7fb-108a-4783-9a37-8bc05bf28b28SPL ID 2021e7fb-108a-4783-9a37-8bc05bf28b28SPL set ID 9de82310-70e8-47b9-b1fc-6c6848b99455RxCUI 577348, 603162UNII 901AS54I69UPC 0364764805302
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

N464764080510 followed by a unit qualifier and the quantity

Package 64764-0805-10. 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 Apr 15, 2026.

Indications (excerpt from the label)

ROZEREM ® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] . ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)