Eszopiclone
- Product NDC
- 50436-5538
- 11-digit product format
- 504365538
- Labeler code
- 50436
- Product ID
- 50436-5538_217153c5-d085-43a3-92a8-5b2cbda2dbd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA091169
- Marketing category
- ANDA
- Marketing start
- 2014-04-14
- Marketing end
- 0000-00-00
- Substance
- ESZOPICLONE
- Active strength
- 2 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 50436-5538-1 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 11 |
| 50436-5538-4 | Eszopiclone | 100 in 1 BOTTLE | 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 [UNIT DOSE SERVICES] | 7 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-5538 | ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] | 11 | Legacy NDC, 2 package rows | 20170615_48925d07-1e06-4761-bbdc-d8b7e70ad155.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-5538-1 | 50436553801 | 30 in 1 BOTTLE | Historical |
| 50436-5538-4 | 50436553804 | 100 in 1 BOTTLE | Historical |