Eszopiclone
- Product NDC
- 68180-324
- 11-digit product format
- 681800324
- Labeler code
- 68180
- Product ID
- 68180-324_a3530781-6fea-425f-9958-eeb2d0b3c696
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA091124
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Substance
- ESZOPICLONE
- Active strength
- 3 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 | 3 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 |
|---|
| 68180-324-01 | Eszopiclone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 15 |
| 68180-324-02 | Eszopiclone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 68180-324-03 | Eszopiclone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 15 |
| 68180-324-11 | Eszopiclone | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESZOPICLONE | ACTIVE INGREDIENT | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| ESZOPICLONE | ACTIVE MOIETY | UZX80K71OE | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-324 | ESZOPICLONE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20240118_7068c455-691e-4c56-9857-b7b4e13f4784.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 |
|---|
| 68180-324-01 | 68180032401 | 100 TABLET, FILM COATED in 1 BOTTLE (68180-324-01) | | 2014-04-15 | 0000-00-00 | No | No | Current |
| 68180-324-02 | 68180032402 | 500 TABLET, FILM COATED in 1 BOTTLE (68180-324-02) | | 2014-04-15 | 0000-00-00 | No | No | Current |
| 68180-324-03 | 68180032403 | 1000 TABLET, FILM COATED in 1 BOTTLE (68180-324-03) | | 2014-04-15 | 0000-00-00 | No | No | Current |
| 68180-324-11 | 68180032411 | 14 in 1 BLISTER PACK | | | | | | Historical |
| 68180-324-13 | 68180032413 | 7 BLISTER PACK in 1 CARTON (68180-324-13) > 14 TABLET, FILM COATED in 1 BLISTER PACK (68180-324-11) | 7 blister pack | 2014-04-15 | 0000-00-00 | No | No | Current |