Ramelteon NDC 0904-7494

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7494Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7494Add 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
0904-7494-06	00904749406	50 BLISTER PACK in 1 CARTON (0904-7494-06) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 10, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211567
Marketing start: Jan 10, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 0904-7494_da88d67f-2c67-461d-a910-263a6e036d83SPL ID da88d67f-2c67-461d-a910-263a6e036d83SPL set ID 44be28b2-f079-40ce-b86d-8b60eda1a7c0RxCUI 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

N400904749406 followed by a unit qualifier and the quantity

Package 00904-7494-06. 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 Mar 16, 2026.

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 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	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	American Health Packaging	60687-692
Ramelteon	Ramelteon 8 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1495