Ramelteon
- Product NDC
- 72162-2169
- 11-digit product format
- 721622169
- Labeler code
- 72162
- Product ID
- 72162-2169_8d67f7ec-a03b-4bf7-9cd6-b31c1a27e82c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091693
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
- Listing expiration
- 2026-12-31
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 |
|---|
| 72162-2169-3 | Ramelteon | 30 in 1 BOTTLE | TABLET | 30 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2169 | RAMELTEON TABLET [BRYANT RANCH PREPACK] | 100 | Current NDC, 1 package rows | 20231212_57536bd9-7dfa-4be5-854a-95fea43d54bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2169-3 | 72162216903 | 30 TABLET in 1 BOTTLE (72162-2169-3) | 30 tablet | 2023-12-07 | No | No | Current |