Ramelteon NDC 42571-375

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-375Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0375Add 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
42571-375-01	42571037501	100 TABLET in 1 BOTTLE (42571-375-01)Marketed from May 1, 2023
42571-375-05	42571037505	500 TABLET in 1 BOTTLE (42571-375-05)Marketed from May 1, 2023
42571-375-30	42571037530	30 TABLET in 1 BOTTLE (42571-375-30)Marketed from May 1, 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: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215243
Marketing start: May 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 42571-375_336c8c9f-7af0-d608-e063-6394a90a5e21SPL ID 336c8c9f-7af0-d608-e063-6394a90a5e21SPL set ID 7545c79a-93ea-4f73-beb5-cac46b2ed7e9RxCUI 577348UNII 901AS54I69UPC 0342571375300
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

N442571037501 followed by a unit qualifier and the quantity

Package 42571-0375-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 215243

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

FDA NDC Directory listings under ANDA 215243
Product	Strength	Form · route	Labeler	Product NDC
Ramelteon	Ramelteon 8 mg/1	TabletOral	Sportpharm LLC	85766-251
Ramelteon	Ramelteon 8 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0593
Ramelteon	Ramelteon 8 mg/1	TabletOral	AvPAK	50268-822
Ramelteon	Ramelteon 8 mg/1	TabletOral	ASCLEMED USA INC.	87063-189
Ramelteon	Ramelteon 8 mg/1	TabletOral	Bryant Ranch Prepack	71335-2310