Ramelteon
- Product NDC
- 85742-023
- 11-digit product format
- 857420023
- Labeler code
- 85742
- Product ID
- 85742-023_cb93cc24-9441-4f57-ad46-92f2f09ccc02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kanchan Healthcare Inc
- Application
- ANDA215435
- Marketing category
- ANDA
- Marketing start
- 2026-04-21
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RAMELTEON | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 901AS54I69 |
| Rxcui | 577348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85742-023-22 | Ramelteon | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 85742-023-23 | Ramelteon | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85742-023-22 | 85742002322 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85742-023-22) | 2026-04-21 | No | No | Historical |
| 85742-023-23 | 85742002323 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85742-023-23) | 2026-04-21 | No | No | Historical |