Prescription drug · ANDA
Ramelteon NDC 10135-838
Ramelteon 8 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-838-01 | 10135083801 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-01)Marketed from Jul 1, 2026 | |
| 10135-838-30 | 10135083830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-838-30)Marketed from Jul 1, 2026 |
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
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215435
- Marketing start
- Listing expires
- Other FDA classes
- Melatonin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 10135-838_56d1aa94-e21a-4ed2-e063-6294a90aa714SPL ID 56d1aa94-e21a-4ed2-e063-6294a90aa714SPL set ID 56d1ac8d-5131-4eed-e063-6294a90a402eRxCUI 577348UNII 901AS54I69UPC 0310135838011
- 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
N410135083801followed by a unit qualifier and the quantityPackage 10135-0838-01. 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 215435
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.