Search by Drug Name or NDC
NDC 00378-4415-01 Flurazepam Hydrochloride 15 mg/1 Details
Flurazepam Hydrochloride 15 mg/1
Flurazepam Hydrochloride is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is FLURAZEPAM HYDROCHLORIDE.
MedlinePlus Drug Summary
Flurazepam is used to treat insomnia (difficulty falling asleep and staying asleep). Flurazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow sleep.
Related Packages: 00378-4415-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Flurazepam
Product Information
| NDC | 00378-4415 |
|---|---|
| Product ID | 0378-4415_66fa1d6a-ee0e-4145-b5fc-52a12f7d0c95 |
| Associated GPIs | 60201010100105 |
| GCN Sequence Number | 003691 |
| GCN Sequence Number Description | flurazepam HCl CAPSULE 15 MG ORAL |
| HIC3 | H21 |
| HIC3 Description | SEDATIVE-HYPNOTICS - BENZODIAZEPINES |
| GCN | 14250 |
| HICL Sequence Number | 001593 |
| HICL Sequence Number Description | FLURAZEPAM HCL |
| Brand/Generic | Generic |
| Proprietary Name | Flurazepam Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | flurazepam hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | FLURAZEPAM HYDROCHLORIDE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA070345 |
| Listing Certified Through | n/a |
Package
NDC 00378-4415-01 (00378441501)
| NDC Package Code | 0378-4415-01 |
|---|---|
| Billing NDC | 00378441501 |
| Package | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4415-01) |
| Marketing Start Date | 1985-11-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |