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NDC 65162-0583-11 Temazepam 7.5 mg/1 Details
Temazepam 7.5 mg/1
Temazepam is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is TEMAZEPAM.
MedlinePlus Drug Summary
Temazepam is used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). Temazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow sleep.
Related Packages: 65162-0583-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Temazepam
Product Information
| NDC | 65162-0583 |
|---|---|
| Product ID | 65162-583_a2863e69-bf07-4c96-807f-f33bb38a4ecc |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Temazepam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Temazepam |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 7.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | TEMAZEPAM |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA203482 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0583-11 (65162058311)
| NDC Package Code | 65162-583-11 |
|---|---|
| Billing NDC | 65162058311 |
| Package | 1000 CAPSULE in 1 BOTTLE (65162-583-11) |
| Marketing Start Date | 2016-05-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |