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 NDC11-digit (billing)PackageCopy
60687-692-65606870692656068706926550 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 PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211567
Marketing start
Listing expires
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 .

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)

About NDC 60687-692

What is NDC 60687-692?
60687-692 is the product NDC for Ramelteon, Ramelteon 8 mg/1 tablet, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 60687. 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/1Tablet, Film coatedOralREMEDYREPACK INC.70518-425770518-4257-00
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

All 38 Ramelteon NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
RamelteonRamelteon 8 mg/1TabletOralMajor Pharmaceuticals0904-7494
RamelteonRamelteon 8 mg/1TabletOralZydus Pharmaceuticals USA Inc.70710-1344
RamelteonRamelteon 8 mg/1TabletOralZydus Lifesciences Limited70771-1495
RamelteonRamelteon 8 mg/1TabletOralBryant Ranch Prepack71335-1853
RamelteonRamelteon 8 mg/1TabletOralDIRECT RX72189-153
RamelteonRamelteon 8 mg/1TabletOralAsclemed USA, Inc.76420-628

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