ESZOPICLONE
- Product NDC
- 50436-0320
- 11-digit product format
- 504360320
- Labeler code
- 50436
- Product ID
- 50436-0320_171b21a8-23e9-46d4-a654-212168967e93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA091113
- Marketing category
- ANDA
- Marketing start
- 2014-09-25
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 1 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f65008ed-f925-2246-581a-e6a3201df7e4 | Product name | 5 | 20250107 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0320-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5582-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0320-1 | ESZOPICLONE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-0320-1 | EA - Each | 50436-0320 | cad1a70f-b6f4-42d6-b793-9b81e93a82b8 | 1 | 2017-09-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0320 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 9 | Legacy NDC, 1 package rows | 20171108_97990015-be86-4f6d-a1bb-f15c187a8e9f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485440 | eszopiclone 1 MG Oral Tablet | PSN | 97990015-be86-4f6d-a1bb-f15c187a8e9f | 9 |
| 485465 | eszopiclone 3 MG Oral Tablet | PSN | 97990015-be86-4f6d-a1bb-f15c187a8e9f | 9 |
| 485440 | eszopiclone 1 MG Oral Tablet | SCD | 97990015-be86-4f6d-a1bb-f15c187a8e9f | 9 |
| 485465 | eszopiclone 3 MG Oral Tablet | SCD | 97990015-be86-4f6d-a1bb-f15c187a8e9f | 9 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-0320-1 | 50436032001 | 30 in 1 BOTTLE | Historical |