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NDC 00406-9915-03 RESTORIL 7.5 mg/1 Details
RESTORIL 7.5 mg/1
RESTORIL is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by SpecGx 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: 00406-9915-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Temazepam
Product Information
| NDC | 00406-9915 |
|---|---|
| Product ID | 0406-9915_a7bb175a-d42e-4f19-8931-6410b120cb39 |
| Associated GPIs | 60201030000103 |
| GCN Sequence Number | 019182 |
| GCN Sequence Number Description | temazepam CAPSULE 7.5 MG ORAL |
| HIC3 | H21 |
| HIC3 Description | SEDATIVE-HYPNOTICS - BENZODIAZEPINES |
| GCN | 13845 |
| HICL Sequence Number | 001592 |
| HICL Sequence Number Description | TEMAZEPAM |
| Brand/Generic | Brand |
| Proprietary Name | RESTORIL |
| 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 | SpecGx LLC |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | NDA |
| Application Number | NDA018163 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00406-9915-03 (00406991503)
| NDC Package Code | 0406-9915-03 |
|---|---|
| Billing NDC | 00406991503 |
| Package | 30 CAPSULE in 1 BOTTLE (0406-9915-03) |
| Marketing Start Date | 1981-02-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |