Eszopiclone
- Product NDC
- 0093-5537
- 11-digit product format
- 000935537
- Labeler code
- 0093
- Product ID
- 0093-5537_efcf4106-ac0a-4f8b-bcd0-743e45e66924
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA091169
- Marketing category
- ANDA
- Marketing start
- 2014-04-14
- Marketing end
- 2027-01-31
- Substance
- ESZOPICLONE
- Active strength
- 1 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eszopiclone
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESZOPICLONE | 1 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 |
|---|
| 0093-5537-56 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5537 | ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20211102_2435e2f1-bc52-488f-80e9-f1758e354aae.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 |
|---|
| 0093-5537-56 | 00093553756 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-5537-56) | 2014-04-14 | 2027-01-31 | No | No | Current |