Lunesta
- Product NDC
- 52959-919
- 11-digit product format
- 529590919
- Labeler code
- 52959
- Product ID
- 52959-919_feff9e75-95ba-4fb3-b286-c363cf4ea678
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA021476
- Marketing category
- NDA
- Marketing start
- 2005-04-04
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 2 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52959-919-00 | Lunesta | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 3 |
| 52959-919-30 | Lunesta | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 3 |
| 52959-919-60 | Lunesta | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-919 | LUNESTA (ESZOPICLONE) TABLET, COATED [H.J. HARKINS COMPANY, INC.] | 3 | Legacy NDC, 3 package rows | 20120120_1f468b3f-7edf-44aa-81e2-ddb1cc0c1724.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-919-00 | 52959091900 | 100 in 1 BOTTLE | Historical |
| 52959-919-30 | 52959091930 | 30 in 1 BOTTLE | Historical |
| 52959-919-60 | 52959091960 | 60 in 1 BOTTLE | Historical |