Ramelteon
- Product NDC
- 43598-741
- 11-digit product format
- 435980741
- Labeler code
- 43598
- Product ID
- 43598-741_54220029-c5df-b277-af7e-2786da03bbed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA091693
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- Marketing end
- 2026-07-31
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
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 |
|---|
| 43598-741-01 | Ramelteon | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 43598-741-10 | Ramelteon | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 43598-741-30 | Ramelteon | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-741 | RAMELTEON TABLET [DR.REDDYS LABORATORIES INC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20220304_b71cd925-1bae-5a6a-072b-941ad6d3ce65.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-741-01 | 43598074101 | 100 TABLET in 1 BOTTLE (43598-741-01) | 100 tablet | 2019-07-22 | 2026-07-31 | No | No | Current |
| 43598-741-10 | 43598074110 | 1000 TABLET in 1 BOTTLE (43598-741-10) | 1000 tablet | 2019-07-22 | 0000-00-00 | No | No | Current |
| 43598-741-30 | 43598074130 | 30 TABLET in 1 BOTTLE (43598-741-30) | 30 tablet | 2019-07-22 | 2026-07-09 | No | No | Current |