Eszopiclone
- Product NDC
- 31722-857
- 11-digit product format
- 317220857
- Labeler code
- 31722
- Product ID
- 31722-857_2e8f0952-b678-2e0a-e063-6294a90aaf4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA205504
- Marketing category
- ANDA
- Marketing start
- 2024-01-04
- Substance
- ESZOPICLONE
- Active strength
- 3 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485440, 485442, 485465 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-857-01 | Eszopiclone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 31722-857-30 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-857 | ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250223_00fc3250-3e29-4a4b-ac0c-74910659337c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-857-01 | 31722085701 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-857-01) | 2024-01-04 | No | No | Current |
| 31722-857-30 | 31722085730 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-857-30) | 2024-01-04 | No | No | Current |