Prescription drug · ANDA
Ramelteon NDC 70518-4257
Ramelteon 8 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4257-0 | 7051842570070518425700 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4257-0)Marketed from Jan 20, 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
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-4257_5a7029de-d11d-4321-e063-6394a90adaf3SPL ID 5a7029de-d11d-4321-e063-6394a90adaf3SPL set ID 5a3cf917-3569-4fc1-8b81-ffecfd2de005RxCUI 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
N470518425700followed by a unit qualifier and the quantityPackage 70518-4257-00. 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.
About NDC 70518-4257
- What is NDC 70518-4257?
- 70518-4257 is the product NDC for Ramelteon, Ramelteon 8 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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.
Related NDCs: other Ramelteon products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0593 | 80425-0593-01 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-838 | 10135-0838-0110135-0838-30 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | AvPAK | 50268-822 | 50268-0822-15 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2644 | 72162-2644-0172162-2644-03 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Kanchan Healthcare Inc | 85742-023 | 85742-0023-2285742-0023-23 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7494 | 00904-7494-06 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-505 | 59651-0505-0159651-0505-30 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2411 | 71335-2411-0171335-2411-02 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-880 | 76420-0880-0176420-0880-3076420-0880-60+1 more |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0343 | 80425-0343-01 |
Other NDCs under ANDA 213815
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 | Upsher-Smith Laboratories, LLC | 0832-1250 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2161 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-484 |
| Ramelteon | Ramelteon 8 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0343 |