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NDC 43353-0312-10 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: 43353-0312-10Last Updated: 04/14/2024
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 43353-0312-10 (43353031210)
NDC Package Code | 43353-312-10 |
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Billing NDC | 43353031210 |
Package | 10 CAPSULE in 1 BOTTLE (43353-312-10) |
Marketing Start Date | 2018-06-27 |
NDC Exclude Flag | N |
Pricing Information | N/A |