Ramelteon NDC 72162-2169

NDC codes

FDA NDC Directory

Product NDC (as listed)72162-2169Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72162-2169Add 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
72162-2169-3	72162216903	30 TABLET in 1 BOTTLE (72162-2169-3)Marketed from Dec 7, 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): Ramelteon
Generic name (nonproprietary): ramelteon
Active ingredients: Ramelteon — 8 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091693
Marketing start: Jul 22, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 72162-2169_8d67f7ec-a03b-4bf7-9cd6-b31c1a27e82cSPL ID 8d67f7ec-a03b-4bf7-9cd6-b31c1a27e82cSPL set ID 57536bd9-7dfa-4be5-854a-95fea43d54bcRxCUI 577348UNII 901AS54I69
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

N472162216903 followed by a unit qualifier and the quantity

Package 72162-2169-03. 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 Dec 7, 2023.

Indications (excerpt from the label)

Ramelteon tablets are 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 )] Ramelteon tablets are 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)