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NDC 00054-3188-63 Diazepam 5 mg/5mL Details
Diazepam 5 mg/5mL
Diazepam is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is DIAZEPAM.
MedlinePlus Drug Summary
Diazepam is used to relieve anxiety and to control agitation caused by alcohol withdrawal. It is also used along with other medications to control muscle spasms and spasticity caused by certain neurological disorders such as cerebral palsy (condition that causes difficulty with movement and balance), paraplegia (inability to move parts of the body), athetosis (abnormal muscle contractions), and stiff-man syndrome (a rare disorder with muscle rigidity and stiffness). Diazepam is also used along with other medications to control seizures. Diazepam is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.
Related Packages: 00054-3188-63Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diazepam
Product Information
| NDC | 00054-3188 |
|---|---|
| Product ID | 0054-3188_864ad9d2-0438-458b-9238-1cbe07e6c835 |
| Associated GPIs | 57100040002001 |
| GCN Sequence Number | 003764 |
| GCN Sequence Number Description | diazepam SOLUTION 5 MG/5 ML ORAL |
| HIC3 | H20 |
| HIC3 Description | ANTI-ANXIETY - BENZODIAZEPINES |
| GCN | 45560 |
| HICL Sequence Number | 001615 |
| HICL Sequence Number Description | DIAZEPAM |
| Brand/Generic | Generic |
| Proprietary Name | Diazepam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diazepam |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DIAZEPAM |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA070928 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-3188-63 (00054318863)
| NDC Package Code | 0054-3188-63 |
|---|---|
| Billing NDC | 00054318863 |
| Package | 500 mL in 1 BOTTLE, PLASTIC (0054-3188-63) |
| Marketing Start Date | 1987-04-03 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.10298 |
| Pricing Unit | ML |
| Effective Date | 2024-01-17 |
| NDC Description | DIAZEPAM 5 MG/5 ML SOLUTION |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |