ZALEPLON is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Zaleplon.
Product ID | 65862-214_2809e4a5-1408-4a3f-bae5-1bfaa1a4a546 |
NDC | 65862-214 |
Product Type | Human Prescription Drug |
Proprietary Name | ZALEPLON |
Generic Name | Zaleplon |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2008-06-06 |
Marketing Category | ANDA / DRUG FOR FURTHER PROCESSING |
Application Number | ANDA078829 |
Labeler Name | Aurobindo Pharma Limited |
Substance Name | ZALEPLON |
Active Ingredient Strength | 5 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 | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2008-06-06 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA078829 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2008-06-06 |
Marketing Category | ANDA |
Application Number | ANDA078829 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2010-06-28 |
Marketing End Date | 2012-07-02 |
Marketing Category | ANDA |
Application Number | ANDA078829 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2008-06-06 |
Ingredient | Strength |
---|---|
ZALEPLON | 5 mg/1 |
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 |