Ramelteon NDC 51407-523

NDC codes

FDA NDC Directory

Product NDC (as listed)51407-523Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51407-0523Add 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
51407-523-01	51407052301	100 TABLET, FILM COATED in 1 BOTTLE (51407-523-01)Marketed from Aug 29, 2024
51407-523-30	51407052330	30 TABLET, FILM COATED in 1 BOTTLE (51407-523-30)Marketed from Aug 29, 2024

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): Ramelteon
Generic name (nonproprietary): ramelteon
Active ingredients: Ramelteon — 8 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Golden State Medical Supply, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216209
Marketing start: Nov 25, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 51407-523_2294061c-8ed1-8b41-e063-6394a90ada58SPL ID 2294061c-8ed1-8b41-e063-6394a90ada58SPL set ID 229403c5-de9c-dc61-e063-6394a90a2a70RxCUI 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

N451407052301 followed by a unit qualifier and the quantity

Package 51407-0523-01. 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 Sep 20, 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 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)

Other NDCs under ANDA 216209

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

FDA NDC Directory listings under ANDA 216209
Product	Strength	Form · route	Labeler	Product NDC
Ramelteon	Ramelteon 8 mg/1	Tablet, Film coatedOral	Xiromed, LLC	70700-272