NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2161Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2161Add 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
72162-2161-3721622161037216221610330 TABLET, FILM COATED in 1 BOTTLE (72162-2161-3)Marketed from Oct 26, 2020

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
Bryant Ranch PrepackNDC labeler code 72162
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 72162-2161_309db764-6abc-4119-b781-8967382d9b39SPL ID 309db764-6abc-4119-b781-8967382d9b39SPL set ID 86296f99-efef-4cbb-84cb-097b2edcfe9cRxCUI 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

N472162216103 followed by a unit qualifier and the quantity

Package 72162-2161-03. 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)

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 month 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 72162-2161

What is NDC 72162-2161?
72162-2161 is the product NDC for Ramelteon, Ramelteon 8 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 72162. 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 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 coatedOralREMEDYREPACK INC.70518-4257
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralDirect_Rx72189-484
RamelteonRamelteon 8 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0343

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