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NDC 00054-9628-57 sodium oxybate 0.5 g/mL Details
sodium oxybate 0.5 g/mL
sodium oxybate is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is SODIUM OXYBATE.
Product Information
| NDC | 00054-9628 |
|---|---|
| Product ID | 0054-9628_d1edb735-8860-4240-8e24-d50f23222d31 |
| Associated GPIs | |
| GCN Sequence Number | 050813 |
| GCN Sequence Number Description | sodium oxybate SOLUTION 500 MG/ML ORAL |
| HIC3 | H7W |
| HIC3 Description | ANTI-NARCOLEPSY,ANTI-CATAPLEXY,SEDATIVE-TYPE AGENT |
| GCN | 18104 |
| HICL Sequence Number | 012346 |
| HICL Sequence Number Description | SODIUM OXYBATE |
| Brand/Generic | Generic |
| Proprietary Name | sodium oxybate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium oxybate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | g/mL |
| Substance Name | SODIUM OXYBATE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE] |
| DEA Schedule | CIII |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA021196 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-9628-57 (00054962857)
| NDC Package Code | 0054-9628-57 |
|---|---|
| Billing NDC | 00054962857 |
| Package | 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57) |
| Marketing Start Date | 2023-01-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |