Ramelteon NDC 80425-0343

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0343Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0343Add 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
80425-0343-1	80425034301	30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1)Marketed from Jun 15, 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, Film coated
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213815
Marketing start: Jun 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4SPL ID 2a9bf7d3-46de-0dfa-e063-6394a90a76a4SPL set ID fe2fc3b7-4600-c14e-e053-6394a90a2586RxCUI 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

N480425034301 followed by a unit qualifier and the quantity

Package 80425-0343-01. 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 31, 2024.

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 month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213815

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213815
Product	Strength	Form · route	Labeler	Product NDC
Ramelteon	Ramelteon 8 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4257
Ramelteon	Ramelteon 8 mg/1	Tablet, Film coatedOral	Upsher-Smith Laboratories, LLC	0832-1250
Ramelteon	Ramelteon 8 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-484
Ramelteon	Ramelteon 8 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2161