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NDC 00054-3185-44 Diazepam Intensol 5 mg/mL Details
Diazepam Intensol 5 mg/mL
Diazepam Intensol is a ORAL SOLUTION, CONCENTRATE 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: 00054-3185-44Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diazepam
Product Information
| NDC | 00054-3185 |
|---|---|
| Product ID | 0054-3185_26a8ed82-5cfc-4b3e-8a19-80b236c1ee0b |
| Associated GPIs | 57100040001310 |
| GCN Sequence Number | 003765 |
| GCN Sequence Number Description | diazepam ORAL CONC 5 MG/ML ORAL |
| HIC3 | H20 |
| HIC3 Description | ANTI-ANXIETY - BENZODIAZEPINES |
| GCN | 45500 |
| HICL Sequence Number | 001615 |
| HICL Sequence Number Description | DIAZEPAM |
| Brand/Generic | Generic |
| Proprietary Name | Diazepam Intensol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diazepam Intensol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION, CONCENTRATE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | DIAZEPAM |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA071415 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-3185-44 (00054318544)
| NDC Package Code | 0054-3185-44 |
|---|---|
| Billing NDC | 00054318544 |
| Package | 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE |
| Marketing Start Date | 1987-04-03 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.78996 |
| Pricing Unit | ML |
| Effective Date | 2021-10-20 |
| NDC Description | DIAZEPAM 5 MG/ML ORAL CONC |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-10-12 |