Prescription drug · ANDA
Ramelteon NDC 70771-1495
Ramelteon 8 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1495-1 | 70771149501 | 100 TABLET in 1 BOTTLE (70771-1495-1)Marketed from Jul 23, 2019 | |
| 70771-1495-3 | 70771149503 | 30 TABLET in 1 BOTTLE (70771-1495-3)Marketed from Jul 23, 2019 | |
| 70771-1495-5 | 70771149505 | 500 TABLET in 1 BOTTLE (70771-1495-5)Marketed from Jul 23, 2019 |
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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211567
- Marketing start
- Listing expires
- Other FDA classes
- Melatonin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70771-1495_5adaa941-43ea-41a8-944f-598d38132c99SPL ID 5adaa941-43ea-41a8-944f-598d38132c99SPL set ID 14ba7994-476a-4978-8cac-29989335a63cRxCUI 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
N470771149501followed by a unit qualifier and the quantityPackage 70771-1495-01. 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 .
Other NDCs under ANDA 211567
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 | Asclemed USA, Inc. | 76420-628 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7494 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1853 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | DIRECT RX | 72189-153 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1344 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | American Health Packaging | 60687-692 |