ESZOPICLONE
- Product NDC
- 42043-322
- 11-digit product format
- 420430322
- Labeler code
- 42043
- Product ID
- 42043-322_7520c868-9116-455c-be63-006171333465
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- OrchidPharma Inc
- Application
- ANDA091113
- Marketing category
- ANDA
- Marketing start
- 2014-09-25
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 3 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 42043-322-01 | 2024-12-20 | C162847 | 48780-1 | 0191ceaa-633c-198a-e063-dbdaa90aec3e | 33bc1c5f-c8cf-4c91-ad78-89d1d68d245d |
| 42043-322-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-633c-198a-e063-dbdaa90aec3e | 33bc1c5f-c8cf-4c91-ad78-89d1d68d245d |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42043-322-01 | EA - Each | 42043-322 | 75fecd87-ff65-406d-a7ac-c0222121fc9c | 1 | 2014-10-03 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485465 | eszopiclone 3 MG Oral Tablet | PSN | 2fd7fa6e-bb39-410b-8676-91ff34c2ce1e | 102 |
| 485465 | eszopiclone 3 MG Oral Tablet | SCD | 2fd7fa6e-bb39-410b-8676-91ff34c2ce1e | 102 |
| 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 |
| 485465 | eszopiclone 3 MG Oral Tablet | PSN | 2cedcc9d-ab83-3b5a-e054-00144ff8d46c | 2 |
| 485465 | eszopiclone 3 MG Oral Tablet | SCD | 2cedcc9d-ab83-3b5a-e054-00144ff8d46c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42043-322-01 | 42043032201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42043-322-01) | 2014-09-25 | 0000-00-00 | No | No | Current |