NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2176Add 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 NDC11-digit (billing)PackageCopy
72162-2176-172162217601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-2176-1)Marketed from Dec 7, 2023
72162-2176-37216221760330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72162-2176-3)Marketed from Dec 7, 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212650
Marketing start
Listing expires
Other FDA classes
Melatonin Receptor Agonists (Mechanism)
Identifiers
Product ID 72162-2176_bec58568-31c1-479a-a35e-679b280d501aSPL ID bec58568-31c1-479a-a35e-679b280d501aSPL set ID 3c14d79c-ece1-40c7-b725-eeb85d6f347aRxCUI 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

N472162217601 followed by a unit qualifier and the quantity

Package 72162-2176-01. 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 212650

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

FDA NDC Directory listings under ANDA 212650
ProductStrengthForm · routeLabelerProduct NDC
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0203
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2886
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2186
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralTruPharma, LLC52817-235
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralProficient Rx LP82804-216
RamelteonRamelteon 8 mg/1Tablet, Film coatedOrali3 Pharmaceuticals, LLC72319-005
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralDirect_Rx72189-369

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