ZALEPLON is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Zaleplon.
| Product ID | 52959-957_f99f26bc-5e6c-4b5a-9657-6bc3861fa5e5 |
| NDC | 52959-957 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ZALEPLON |
| Generic Name | Zaleplon |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-12-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078989 |
| Labeler Name | H.J. Harkins Company, Inc. |
| Substance Name | ZALEPLON |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] |
| DEA Schedule | CIV |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2010-12-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA078989 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-12-15 |
| Inactivation Date | 2019-10-29 |
| Marketing Category | ANDA |
| Application Number | ANDA078989 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-15 |
| Inactivation Date | 2019-10-29 |
| Ingredient | Strength |
|---|---|
| ZALEPLON | 10 mg/1 |
| SPL SET ID: | 4ccb8d3d-31ef-49ff-8567-c620b9d74f8c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0084 | Zaleplon | Zaleplon |
| 0054-0085 | Zaleplon | Zaleplon |
| 0093-5268 | Zaleplon | Zaleplon |
| 0093-5269 | Zaleplon | Zaleplon |
| 21695-105 | ZALEPLON | ZALEPLON |
| 21695-376 | ZALEPLON | ZALEPLON |
| 29300-131 | zaleplon | zaleplon |
| 29300-132 | zaleplon | zaleplon |
| 33261-454 | zaleplon | zaleplon |
| 33261-486 | zaleplon | zaleplon |
| 35356-656 | zaleplon | zaleplon |
| 42043-210 | Zaleplon | Zaleplon |
| 42043-211 | Zaleplon | Zaleplon |
| 42254-130 | zaleplon | zaleplon |
| 42254-147 | zaleplon | zaleplon |
| 42254-189 | zaleplon | zaleplon |
| 43063-505 | ZALEPLON | ZALEPLON |
| 43063-783 | zaleplon | zaleplon |
| 43063-912 | Zaleplon | Zaleplon |
| 67877-210 | ZALEPLON | ZALEPLON |
| 67877-211 | ZALEPLON | ZALEPLON |
| 68788-6850 | zaleplon | zaleplon |
| 68788-7208 | zaleplon | zaleplon |
| 71335-0236 | zaleplon | zaleplon |
| 71335-1054 | ZALEPLON | ZALEPLON |
| 45865-541 | zaleplon | zaleplon |
| 50090-1564 | zaleplon | zaleplon |
| 50090-3420 | Zaleplon | Zaleplon |
| 50436-1006 | Zaleplon | Zaleplon |
| 52959-957 | ZALEPLON | ZALEPLON |
| 55700-190 | Zaleplon | Zaleplon |
| 57237-239 | ZALEPLON | ZALEPLON |
| 57237-240 | ZALEPLON | ZALEPLON |
| 61919-629 | ZALEPLON | ZALEPLON |
| 63629-3405 | zaleplon | zaleplon |
| 65862-214 | ZALEPLON | ZALEPLON |
| 65862-215 | ZALEPLON | ZALEPLON |
| 66336-056 | Zaleplon | Zaleplon |