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Xyrem
Xyrem - 68727-100-01 - (sodium oxybate)
Drug Information of Xyrem
| Product NDC: | 68727-100 |
| Proprietary Name: | Xyrem |
| Non Proprietary Name: | sodium oxybate |
| Active Ingredient(s): | .5 g/mL & nbsp; sodium oxybate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Xyrem
| Product NDC: | 68727-100 |
| Labeler Name: | Jazz Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021196 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20020717 |
Package Information of Xyrem
| Package NDC: | 68727-100-01 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (68727-100-01) > 180 mL in 1 BOTTLE, PLASTIC |
NDC Information of Xyrem
| NDC Code | 68727-100-01 |
| Proprietary Name | Xyrem |
| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (68727-100-01) > 180 mL in 1 BOTTLE, PLASTIC |
| Product NDC | 68727-100 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | sodium oxybate |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20020717 |
| Marketing Category Name | NDA |
| Labeler Name | Jazz Pharmaceuticals, Inc. |
| Substance Name | SODIUM OXYBATE |
| Strength Number | .5 |
| Strength Unit | g/mL |
| Pharmaceutical Classes | Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE] |
