ZOLPIDEM TARTRATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Zolpidem Tartrate.
| Product ID | 53002-1292_731f90ad-1acc-44df-a71a-012403a98d53 |
| NDC | 53002-1292 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ZOLPIDEM TARTRATE |
| Generic Name | Zolpidem Tartrate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2007-09-05 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA077903 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | ZOLPIDEM TARTRATE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE] |
| DEA Schedule | CIV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077903 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA077903 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA077903 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| ZOLPIDEM TARTRATE | 5 mg/1 |
| SPL SET ID: | 96d08f88-c841-46d6-958d-7f45656e672c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0086 | Zolpidem Tartrate | zolpidem tartrate |
| 0054-0087 | Zolpidem Tartrate | zolpidem tartrate |
| 0093-0073 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0093-0074 | Zolpidem Tartrate | Zolpidem Tartrate |
| 67544-996 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68071-1895 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68071-1997 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68071-1887 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68071-4089 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68071-4598 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68084-523 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68084-189 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68180-779 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68180-780 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68788-7182 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68788-7407 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68788-9126 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68788-9282 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68788-9278 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68788-8971 | Zolpidem Tartrate | Zolpidem Tartrate |
| 68788-9127 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 68788-8970 | Zolpidem Tartrate | Zolpidem Tartrate |
| 70518-0161 | Zolpidem Tartrate | Zolpidem Tartrate |
| 70518-1663 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71335-0079 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71335-0154 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 71335-0283 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71335-0134 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71610-151 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71610-192 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71610-152 | Zolpidem Tartrate | Zolpidem Tartrate |
| 71610-156 | Zolpidem Tartrate | Zolpidem Tartrate |
| 75921-469 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0615-8047 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0615-8046 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0615-8226 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0615-8225 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0781-5315 | Zolpidem tartrate | Zolpidem tartrate |
| 0781-5316 | Zolpidem tartrate | Zolpidem tartrate |
| 0781-5318 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0781-5317 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0904-6082 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 0904-6083 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 0955-1703 | Zolpidem Tartrate | Zolpidem Tartrate |
| 10544-539 | Zolpidem Tartrate | Zolpidem Tartrate |
| 0955-1702 | Zolpidem Tartrate | Zolpidem Tartrate |
| 10544-040 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 10544-548 | Zolpidem Tartrate | Zolpidem Tartrate |
| 10544-540 | Zolpidem Tartrate | Zolpidem Tartrate |
| 12634-944 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |