NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4257Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4257Add 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
70518-4257-0705184257007051842570030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4257-0)Marketed from Jan 20, 2025

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
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213815
Marketing start
Listing expires
Other FDA classes
Melatonin Receptor Agonists (Mechanism)
Identifiers
Product ID 70518-4257_5a7029de-d11d-4321-e063-6394a90adaf3SPL ID 5a7029de-d11d-4321-e063-6394a90adaf3SPL set ID 5a3cf917-3569-4fc1-8b81-ffecfd2de005RxCUI 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

N470518425700 followed by a unit qualifier and the quantity

Package 70518-4257-00. 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.

About NDC 70518-4257

What is NDC 70518-4257?
70518-4257 is the product NDC for Ramelteon, Ramelteon 8 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ramelteon.
What is the active ingredient?
Ramelteon.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ramelteon?
37 other product NDCs are listed under this name. See all Ramelteon NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ramelteon NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RamelteonRamelteon 8 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-059380425-0593-01
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals, Inc.10135-83810135-0838-0110135-0838-30
RamelteonRamelteon 8 mg/1TabletOralAvPAK50268-82250268-0822-15
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-264472162-2644-0172162-2644-03
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralKanchan Healthcare Inc85742-02385742-0023-2285742-0023-23
RamelteonRamelteon 8 mg/1TabletOralMajor Pharmaceuticals0904-749400904-7494-06
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-50559651-0505-0159651-0505-30
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-241171335-2411-0171335-2411-02
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-88076420-0880-0176420-0880-3076420-0880-60+1 more
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-034380425-0343-01

All 38 Ramelteon NDCs

Other NDCs under ANDA 213815

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

FDA NDC Directory listings under ANDA 213815
ProductStrengthForm · routeLabelerProduct NDC
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralUpsher-Smith Laboratories, LLC0832-1250
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2161
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralDirect_Rx72189-484
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0343

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