Eszopiclone
- Product NDC
- 0378-5272
- 11-digit product format
- 003785272
- Labeler code
- 0378
- Product ID
- 0378-5272_850bc29d-2353-4e1f-bfe4-0811eb79000f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA091151
- Marketing category
- ANDA
- Marketing start
- 2013-03-26
- Substance
- ESZOPICLONE
- Active strength
- 3 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESZOPICLONE | 3 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 |
|---|
| 0378-5272-01 | Eszopiclone | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-5272 | ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20221102_5469cc59-78f9-447a-9c33-12553bb4073d.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 |
|---|
| 0378-5272-01 | 00378527201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5272-01) | 2013-03-26 | 0000-00-00 | No | No | Current |