ESZOPICLONE
- Product NDC
- 63187-579
- 11-digit product format
- 631870579
- Labeler code
- 63187
- Product ID
- 63187-579_a923089b-eeab-4a61-876f-9e77b896e719
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-579 | ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Legacy NDC | 20191121_0a3441ae-9831-48e8-9444-510c9e7d226b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-579-30 | 63187057930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-579-30) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-579-60 | 63187057960 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-579-60) | 2018-12-01 | 0000-00-00 | No | No | Current |
| 63187-579-90 | 63187057990 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-579-90) | 2018-12-01 | 0000-00-00 | No | No | Current |