Prescription drug · ANDA
Ramelteon NDC 71335-2886
Ramelteon 8 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2886-1 | 71335288601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2886-1)Marketed from Oct 28, 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
- Bryant Ranch Prepack
- 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 71335-2886_f56a6da2-455b-4e56-acb3-aaf23586f819SPL ID f56a6da2-455b-4e56-acb3-aaf23586f819SPL set ID b1706aa1-9332-4faf-8d0c-88edd00b15e3RxCUI 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
N471335288601followed by a unit qualifier and the quantityPackage 71335-2886-01. 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.
| 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 | 71335-2186 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-235 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-216 |
| 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 |