Eszopiclone
- Product NDC
- 55111-629
- 11-digit product format
- 551110629
- Labeler code
- 55111
- Product ID
- 55111-629_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA091024
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Substance
- ESZOPICLONE
- Active strength
- 1 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 | 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 |
|---|
| 55111-629-01 | Eszopiclone | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 16 |
| 55111-629-05 | Eszopiclone | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 16 |
| 55111-629-30 | Eszopiclone | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-629 | ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] | 16 | Current NDC, Legacy NDC, 3 package rows | 20241222_0b363b90-93dc-1fc1-0501-d140dfc762c7.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 |
|---|
| 55111-629-01 | 55111062901 | 100 TABLET, COATED in 1 BOTTLE (55111-629-01) | 2014-04-15 | 0000-00-00 | No | No | Current |
| 55111-629-05 | 55111062905 | 500 TABLET, COATED in 1 BOTTLE (55111-629-05) | 2014-04-15 | 0000-00-00 | No | No | Current |
| 55111-629-30 | 55111062930 | 30 TABLET, COATED in 1 BOTTLE (55111-629-30) | 2014-04-15 | 0000-00-00 | No | No | Current |