Ramelteon NDC 60687-692

NDC codes

FDA NDC Directory

Product NDC (as listed)60687-692Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60687-0692Add 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
60687-692-65	60687069265	50 BLISTER PACK in 1 CARTON (60687-692-65) / 1 TABLET in 1 BLISTER PACK (60687-692-11)Marketed from Feb 20, 2023

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
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211567
Marketing start: Feb 20, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 60687-692_1d9ab033-d6bb-3060-e063-6394a90a7c5bSPL ID 1d9ab033-d6bb-3060-e063-6394a90a7c5bSPL set ID 094d5aa0-aa29-4898-928a-fe0d283a5271RxCUI 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

N460687069265 followed by a unit qualifier and the quantity

Package 60687-0692-65. 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 Jul 19, 2024.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE 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 211567

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

FDA NDC Directory listings under ANDA 211567
Product	Strength	Form · route	Labeler	Product NDC
Ramelteon	Ramelteon 8 mg/1	TabletOral	Asclemed USA, Inc.	76420-628
Ramelteon	Ramelteon 8 mg/1	TabletOral	Major Pharmaceuticals	0904-7494
Ramelteon	Ramelteon 8 mg/1	TabletOral	Bryant Ranch Prepack	71335-1853
Ramelteon	Ramelteon 8 mg/1	TabletOral	DIRECT RX	72189-153
Ramelteon	Ramelteon 8 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-1344
Ramelteon	Ramelteon 8 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1495