Prescription drug · ANDA
Ramelteon NDC 71335-2310
Ramelteon 8 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2310-1 | 71335231001 | 30 TABLET in 1 BOTTLE (71335-2310-1)Marketed from Dec 18, 2023 | |
| 71335-2310-2 | 71335231002 | 60 TABLET in 1 BOTTLE (71335-2310-2)Marketed from Dec 18, 2023 |
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
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215243
- Marketing start
- Listing expires
- Other FDA classes
- Melatonin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71335-2310_7fbd3bf9-01ee-47ff-9b0e-49ebe55b3886SPL ID 7fbd3bf9-01ee-47ff-9b0e-49ebe55b3886SPL set ID 4c25cf94-f30e-4940-9f8b-3cb34258ba04RxCUI 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
N471335231001followed by a unit qualifier and the quantityPackage 71335-2310-01. 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
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 tablet is indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215243
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 | TabletOral | Sportpharm LLC | 85766-251 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0593 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | AvPAK | 50268-822 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-189 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Micro Labs Limited | 42571-375 |