ESZOPICLONE
- Product NDC
- 63629-5319
- 11-digit product format
- 636295319
- Labeler code
- 63629
- Product ID
- 63629-5319_29295c36-c640-48a5-8b6b-bae3b559f2c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091103
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 2 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-5319-1 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-2 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-3 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-4 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-5 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-6 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-7 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-8 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-1 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-2 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-3 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-4 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-5 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-6 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-7 | 2020-07-07 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 63629-5319-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eab3-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ESZOPICLONE 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 table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-5319-1 | ESZOPICLONE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1007 |
| 63629-5319-2 | ESZOPICLONE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1007 |
| 63629-5319-3 | ESZOPICLONE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1007 |
| 63629-5319-4 | ESZOPICLONE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1007 |
| 63629-5319-5 | ESZOPICLONE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1007 |
| 63629-5319-6 | ESZOPICLONE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1007 |
| 63629-5319-7 | ESZOPICLONE | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 1007 |
| 63629-5319-8 | ESZOPICLONE | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1007 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-5319 | ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1007 | Legacy NDC, 8 package rows | 20220401_29295c36-c640-48a5-8b6b-bae3b559f2c9.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 |
|---|
| 63629-5319-1 | 63629531901 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-5319-1) | 2014-04-24 | 0000-00-00 | No | No | Current |
| 63629-5319-2 | 63629531902 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-5319-2) | 2014-05-06 | 0000-00-00 | No | No | Current |
| 63629-5319-3 | 63629531903 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-5319-3) | 2022-03-31 | 0000-00-00 | No | No | Current |
| 63629-5319-4 | 63629531904 | 120 TABLET, FILM COATED in 1 BOTTLE (63629-5319-4) | 2022-03-31 | 0000-00-00 | No | No | Current |
| 63629-5319-5 | 63629531905 | 20 TABLET, FILM COATED in 1 BOTTLE (63629-5319-5) | 2022-03-31 | 0000-00-00 | No | No | Current |
| 63629-5319-6 | 63629531906 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-5319-6) | 2022-03-31 | 0000-00-00 | No | No | Current |
| 63629-5319-7 | 63629531907 | 28 TABLET, FILM COATED in 1 BOTTLE (63629-5319-7) | 2016-06-22 | 0000-00-00 | No | No | Current |
| 63629-5319-8 | 63629531908 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-5319-8) | 2022-03-31 | 0000-00-00 | No | No | Current |