Eszopiclone
- Product NDC
- 70518-4361
- 11-digit product format
- 705184361
- Labeler code
- 70518
- Product ID
- 70518-4361_3f2870c4-2c3c-d0f3-e063-6294a90aeac9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205504
- Marketing category
- ANDA
- Marketing start
- 2025-06-17
- Substance
- ESZOPICLONE
- Active strength
- 2 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESZOPICLONE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4361-0 | Eszopiclone | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 70518-4361-1 | Eszopiclone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4361-0 | 70518436100 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4361-0) | 2025-06-17 | No | No | Historical |
| 70518-4361-1 | 70518436101 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4361-1) | 2025-09-19 | No | No | Historical |