Prescription drug · ANDA
Ramelteon NDC 76420-628
Ramelteon 8 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-628-01 | 7642006280176420062801 | 100 TABLET in 1 BOTTLE (76420-628-01)Marketed from Oct 17, 2023 | |
| 76420-628-30 | 7642006283076420062830 | 30 TABLET in 1 BOTTLE (76420-628-30)Marketed from Nov 28, 2023 | |
| 76420-628-60 | 7642006286076420062860 | 60 TABLET in 1 BOTTLE (76420-628-60)Marketed from Nov 28, 2023 | |
| 76420-628-90 | 7642006289076420062890 | 90 TABLET in 1 BOTTLE (76420-628-90)Marketed from Nov 28, 2023 |
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
- Asclemed USA, Inc.NDC labeler code 76420
- 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 76420-628_0b2fcb56-d9fa-e9f6-e063-6294a90a2f8eSPL ID 0b2fcb56-d9fa-e9f6-e063-6294a90a2f8eSPL set ID 208dbac2-2634-4aff-8e2c-e5ecb47145e2RxCUI 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
N476420062801followed by a unit qualifier and the quantityPackage 76420-0628-01. 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 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 76420-628
- What is NDC 76420-628?
- 76420-628 is the product NDC for Ramelteon, Ramelteon 8 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 4 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 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 | Major Pharmaceuticals | 0904-7494 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | American Health Packaging | 60687-692 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1344 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1495 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1853 |
| Ramelteon | Ramelteon 8 mg/1 | TabletOral | DIRECT RX | 72189-153 |