ESZOPICLONE
- Product NDC
- 69452-348
- 11-digit product format
- 694520348
- Labeler code
- 69452
- Product ID
- 69452-348_903d952f-704a-4227-a829-5bddbd5793cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA091113
- Marketing category
- ANDA
- Marketing start
- 2022-06-01
- 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 | 485440, 485442, 485465 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69452-348-20 | ESZOPICLONE | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-348 | ESZOPICLONE TABLET, FILM COATED [BIONPHARMA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231202_ec6ac172-509e-403a-aa0d-4c60010a0035.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69452-348-20 | 69452034820 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-348-20) | 2022-06-01 | 0000-00-00 | No | No | Current |