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NDC 63629-8602-01 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 Bryant Ranch Prepack. 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: 63629-8602-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Temazepam
Product Information
NDC | 63629-8602 |
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Product ID | 63629-8602_ad63b198-9c80-47d6-a755-dffdbd149c96 |
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 | Bryant Ranch Prepack |
Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
DEA Schedule | CIV |
Marketing Category | ANDA |
Application Number | ANDA071456 |
Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8602-01 (63629860201)
NDC Package Code | 63629-8602-1 |
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Billing NDC | 63629860201 |
Package | 100 CAPSULE in 1 BOTTLE (63629-8602-1) |
Marketing Start Date | 2021-07-13 |
NDC Exclude Flag | N |
Pricing Information | N/A |