Temazepam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Temazepam.
| Product ID | 40032-121_8bfc2252-e630-499c-9a04-d408bf9f9b7e |
| NDC | 40032-121 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Temazepam |
| Generic Name | Temazepam |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-10-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA071456 |
| Labeler Name | Novel Laboratories, Inc. |
| Substance Name | TEMAZEPAM |
| Active Ingredient Strength | 15 mg/1 |
| Pharm Classes | Benzodiazepine [EPC],Benzodiazepines [CS] |
| DEA Schedule | CIV |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2009-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA071456 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-10-01 |
| Marketing End Date | 2012-08-12 |
| Marketing Category | ANDA |
| Application Number | ANDA071456 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-10-01 |
| Inactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA071456 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-10-01 |
| Inactivation Date | 2019-11-13 |
| Ingredient | Strength |
|---|---|
| TEMAZEPAM | 15 mg/1 |
| SPL SET ID: | 85327378-86a3-4448-9185-e20bb20ebf45 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0228-2076 | Temazepam | Temazepam |
| 0228-2077 | Temazepam | Temazepam |
| 0378-3110 | Temazepam | temazepam |
| 0378-3120 | Temazepam | temazepam |
| 0378-4010 | Temazepam | temazepam |
| 0378-5050 | Temazepam | temazepam |
| 0406-9959 | TEMAZEPAM | temazepam |
| 0406-9960 | TEMAZEPAM | temazepam |
| 0406-9961 | TEMAZEPAM | temazepam |
| 0406-9962 | TEMAZEPAM | temazepam |
| 0440-8474 | temazepam | temazepam |
| 0440-8475 | temazepam | temazepam |
| 0440-8476 | temazepam | temazepam |
| 0440-8477 | temazepam | temazepam |
| 0615-7808 | Temazepam | Temazepam |
| 0615-7809 | Temazepam | Temazepam |
| 67877-148 | temazepam | temazepam |
| 67877-146 | temazepam | temazepam |
| 67877-149 | temazepam | temazepam |
| 67877-147 | temazepam | temazepam |
| 68071-4083 | Temazepam | Temazepam |
| 68071-4100 | Temazepam | Temazepam |
| 68084-549 | TEMAZEPAM | TEMAZEPAM |
| 68788-6986 | Temazepam | Temazepam |
| 68788-7163 | Temazepam | Temazepam |
| 68788-6904 | Temazepam | Temazepam |
| 70518-0647 | temazepam | temazepam |
| 70518-1944 | Temazepam | Temazepam |
| 70518-1754 | Temazepam | Temazepam |
| 71335-0315 | Temazepam | Temazepam |
| 71335-0527 | Temazepam | Temazepam |
| 71610-004 | TEMAZEPAM | TEMAZEPAM |
| 71610-089 | temazepam | temazepam |
| 71610-086 | temazepam | temazepam |
| 71610-101 | temazepam | temazepam |
| 0781-2201 | Temazepam | Temazepam |
| 0781-2202 | Temazepam | Temazepam |
| 0904-6436 | Temazepam | Temazepam |
| 21695-282 | temazepam | temazepam |
| 21695-283 | temazepam | temazepam |
| 33261-102 | Temazepam | Temazepam |
| 33261-101 | Temazepam | Temazepam |
| 33358-332 | Temazepam | Temazepam |
| 35356-664 | temazepam | temazepam |
| 35356-663 | temazepam | temazepam |
| 35356-821 | temazepam | temazepam |
| 40032-121 | Temazepam | Temazepam |
| 40032-123 | Temazepam | Temazepam |
| 40032-122 | Temazepam | Temazepam |
| 40032-120 | Temazepam | Temazepam |