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NDC 43353-0312-53 temazepam 15 mg/1 Details
temazepam 15 mg/1
temazepam is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, 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: 43353-0312-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Temazepam
Product Information
| NDC | 43353-0312 |
|---|---|
| Product ID | 43353-312_98a12b95-2697-4861-941c-581732972660 |
| Associated GPIs | 60201030000105 |
| GCN Sequence Number | 003689 |
| GCN Sequence Number Description | temazepam CAPSULE 15 MG ORAL |
| HIC3 | H21 |
| HIC3 Description | SEDATIVE-HYPNOTICS - BENZODIAZEPINES |
| GCN | 13840 |
| HICL Sequence Number | 001592 |
| HICL Sequence Number Description | TEMAZEPAM |
| Brand/Generic | Generic |
| 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 | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | TEMAZEPAM |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA071456 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43353-0312-53 (43353031253)
| NDC Package Code | 43353-312-53 |
|---|---|
| Billing NDC | 43353031253 |
| Package | 60 CAPSULE in 1 BOTTLE (43353-312-53) |
| Marketing Start Date | 2017-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |