Prescription drug · ANDA
Ramelteon NDC 71205-918
Ramelteon 8 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-918-00 | 7120509180071205091800 | 100 TABLET in 1 BOTTLE (71205-918-00)Marketed from Jul 7, 2021 | |
| 71205-918-30 | 7120509183071205091830 | 30 TABLET in 1 BOTTLE (71205-918-30)Marketed from Jul 7, 2021 | |
| 71205-918-55 | 7120509185571205091855 | 500 TABLET in 1 BOTTLE (71205-918-55)Marketed from Jul 7, 2021 | |
| 71205-918-60 | 7120509186071205091860 | 60 TABLET in 1 BOTTLE (71205-918-60)Marketed from Jul 7, 2021 | |
| 71205-918-72 | 7120509187271205091872 | 120 TABLET in 1 BOTTLE (71205-918-72)Marketed from Jul 7, 2021 | |
| 71205-918-90 | 7120509189071205091890 | 90 TABLET in 1 BOTTLE (71205-918-90)Marketed from Jul 7, 2021 |
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
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213186
- Marketing start
- Listing expires
- Other FDA classes
- Melatonin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71205-918_c90ef143-aff7-41d6-9171-3e5e7bb6e97eSPL ID c90ef143-aff7-41d6-9171-3e5e7bb6e97eSPL set ID 7ca849d3-f0ba-45b5-9aec-f4b7ea105facRxCUI 577348UNII 901AS54I69UPC 0371205918309
- 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
N471205091800followed by a unit qualifier and the quantityPackage 71205-0918-00. 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
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 tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71205-918
- What is NDC 71205-918?
- 71205-918 is the product NDC for Ramelteon, Ramelteon 8 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 71205. 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 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4257 | 70518-4257-00 |
| 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 |
Other NDCs under ANDA 213186
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 | AvKARE | 42291-776 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8531 |