Eszopiclone
- Product NDC
- 33342-299
- 11-digit product format
- 333420299
- Labeler code
- 33342
- Product ID
- 33342-299_66cfec66-191e-4af9-a623-8464417fab6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202929
- Marketing category
- ANDA
- Marketing start
- 2015-01-31
- 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 |
|---|
| 33342-299-07 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 33342-299-11 | Eszopiclone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 33342-299-12 | Eszopiclone | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 33342-299-12 | Eszopiclone | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
| 33342-299-44 | Eszopiclone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-299 | ESZOPICLONE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 9 | Current NDC, Legacy NDC, 5 package rows | 20221102_12593790-e72f-45b1-8895-987cdd075134.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 33342-299-07 | 33342029907 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-299-07) | | 2015-01-31 | 0000-00-00 | No | No | Current |
| 33342-299-11 | 33342029911 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-299-11) | | 2015-01-31 | 0000-00-00 | No | No | Current |
| 33342-299-12 | 33342029912 | 10 BLISTER PACK in 1 CARTON (33342-299-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2015-01-31 | 0000-00-00 | No | No | Current |
| 33342-299-44 | 33342029944 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-299-44) | | 2015-01-31 | 0000-00-00 | No | No | Current |