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NDC 43386-0280-02 Diazepam 10 mg/2g Details
Diazepam 10 mg/2g
Diazepam is a RECTAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is DIAZEPAM.
MedlinePlus Drug Summary
Diazepam rectal gel is used in emergency situations to stop cluster seizures (episodes of increased seizure activity) in people who are taking other medications to treat epilepsy (seizures). Diazepam is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.
Related Packages: 43386-0280-02Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Diazepam Rectal
Product Information
| NDC | 43386-0280 |
|---|---|
| Product ID | 43386-280_fdfd69c8-d9ae-4e4d-8927-7221f9e5f604 |
| Associated GPIs | |
| GCN Sequence Number | 059781 |
| GCN Sequence Number Description | diazepam KIT 5-7.5-10MG RECTAL |
| HIC3 | H4A |
| HIC3 Description | ANTICONVULSANT - BENZODIAZEPINE TYPE |
| GCN | 25598 |
| 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 | GEL |
| Route | RECTAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/2g |
| Substance Name | DIAZEPAM |
| Labeler Name | Lupin Pharmaceuticals,Inc. |
| Pharmaceutical Class | Benzodiazepine [EPC], Benzodiazepines [CS] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA091076 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43386-0280-02 (43386028002)
| NDC Package Code | 43386-280-02 |
|---|---|
| Billing NDC | 43386028002 |
| Package | 1 PACKAGE in 1 CARTON (43386-280-02) / 2 SYRINGE in 1 PACKAGE (43386-280-01) / 2 g in 1 SYRINGE (43386-280-03) |
| Marketing Start Date | 2023-10-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 270.447 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DIAZEPAM 10 MG RECTAL GEL SYST |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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