Eszopiclone
- Product NDC
- 68462-383
- 11-digit product format
- 684620383
- Labeler code
- 68462
- Product ID
- 68462-383_59fb9200-74d0-472d-a4c7-96c9a4ded89c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc. USA
- Application
- ANDA091166
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Substance
- ESZOPICLONE
- Active strength
- 2 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESZOPICLONE | 2 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 |
|---|
| 68462-383-01 | Eszopiclone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 68462-383-10 | Eszopiclone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-383 | ESZOPICLONE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC. USA] | 10 | Current NDC, Legacy NDC, 2 package rows | 20230116_584dc66c-063a-4552-a056-74b811e2bc80.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 |
|---|
| 68462-383-01 | 68462038301 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-383-01) | 2014-04-15 | 0000-00-00 | No | No | Current |
| 68462-383-10 | 68462038310 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-383-10) | 2014-04-15 | 0000-00-00 | No | No | Current |