ESZOPICLONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Eszopiclone.
| Product ID | 53217-149_eaca04e2-15b7-45a3-9480-1a678ba9c184 |
| NDC | 53217-149 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ESZOPICLONE |
| Generic Name | Eszopiclone |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-09-25 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091113 |
| Labeler Name | Aidarex Pharmaceuticals LLC |
| Substance Name | ESZOPICLONE |
| Active Ingredient Strength | 2 mg/1 |
| DEA Schedule | CIV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2014-09-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091113 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-09-25 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| ESZOPICLONE | 2 mg/1 |
| SPL SET ID: | 29236413-85b8-4c82-be61-0ad66fd9e2c9 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0290 | eszopiclone | eszopiclone |
| 0054-0291 | eszopiclone | eszopiclone |
| 0054-0292 | eszopiclone | eszopiclone |
| 0093-5537 | Eszopiclone | Eszopiclone |
| 0093-5538 | Eszopiclone | Eszopiclone |
| 0093-5539 | Eszopiclone | Eszopiclone |
| 0378-5270 | Eszopiclone | eszopiclone |
| 0378-5271 | Eszopiclone | eszopiclone |
| 0378-5272 | Eszopiclone | eszopiclone |
| 33342-299 | Eszopiclone | Eszopiclone |
| 33342-300 | Eszopiclone | Eszopiclone |
| 33342-301 | Eszopiclone | Eszopiclone |
| 68071-2153 | eszopiclone | eszopiclone |
| 68071-3376 | Eszopiclone | Eszopiclone |
| 68180-322 | Eszopiclone | Eszopiclone |
| 68180-324 | Eszopiclone | Eszopiclone |
| 68180-323 | Eszopiclone | Eszopiclone |
| 68462-382 | Eszopiclone | Eszopiclone |
| 68462-384 | Eszopiclone | Eszopiclone |
| 68462-383 | Eszopiclone | Eszopiclone |
| 68788-7029 | Eszopiclone | Eszopiclone |
| 68788-7169 | Eszopiclone | Eszopiclone |
| 68788-8923 | Eszopiclone | Eszopiclone |
| 68788-9361 | eszopiclone | eszopiclone |
| 68788-9238 | eszopiclone | eszopiclone |
| 68788-6953 | Eszopiclone | Eszopiclone |
| 68788-8953 | ESZOPICLONE | ESZOPICLONE |
| 68788-9296 | ESZOPICLONE | ESZOPICLONE |
| 68788-9315 | ESZOPICLONE | ESZOPICLONE |
| 68788-9824 | ESZOPICLONE | ESZOPICLONE |
| 68788-9318 | Eszopiclone | Eszopiclone |
| 68788-9991 | ESZOPICLONE | ESZOPICLONE |
| 70518-0815 | Eszopiclone | Eszopiclone |
| 70518-0816 | Eszopiclone | Eszopiclone |
| 70518-1310 | ESZOPICLONE | ESZOPICLONE |
| 70518-0888 | Eszopiclone | Eszopiclone |
| 71205-236 | ESZOPICLONE | ESZOPICLONE |
| 71335-0512 | Eszopiclone | Eszopiclone |
| 71335-0089 | Eszopiclone | Eszopiclone |
| 71335-0148 | ESZOPICLONE | ESZOPICLONE |
| 71335-0116 | Eszopiclone | Eszopiclone |
| 71335-0784 | eszopiclone | eszopiclone |
| 71335-0005 | ESZOPICLONE | ESZOPICLONE |
| 71335-0598 | Eszopiclone | Eszopiclone |
| 42043-320 | ESZOPICLONE | ESZOPICLONE |
| 42043-321 | ESZOPICLONE | ESZOPICLONE |
| 42043-322 | ESZOPICLONE | ESZOPICLONE |
| 43063-795 | Eszopiclone | Eszopiclone |
| 43353-101 | Eszopiclone | Eszopiclone |
| 43353-185 | Eszopiclone | Eszopiclone |