Prescription drug · ANDA
Ramelteon NDC 82804-216
Ramelteon 8 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-216-30 | 82804021630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-216-30)Marketed from Apr 17, 2025 |
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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 82804-216_2cb1b48a-05c0-4058-8ccd-1971098b8ce1SPL ID 2cb1b48a-05c0-4058-8ccd-1971098b8ce1SPL set ID 2cb1b48a-05c0-4058-8ccd-1971098b8ce1RxCUI 577348UNII 901AS54I69UPC 0382804216307
- 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
N482804021630followed by a unit qualifier and the quantityPackage 82804-0216-30. 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 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212650
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2176 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0203 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2886 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2186 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-235 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | i3 Pharmaceuticals, LLC | 72319-005 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-369 |