| Product NDC: | 42794-086 |
| Proprietary Name: | Sodium Phenylbutyrate |
| Non Proprietary Name: | Sodium Phenylbutyrate |
| Active Ingredient(s): | .94 g/g & nbsp; Sodium Phenylbutyrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | POWDER |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 42794-086 |
| Labeler Name: | Sigmapharm Laboratories, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202819 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130403 |
| Package NDC: | 42794-086-14 |
| Package Description: | 1 BOTTLE in 1 CARTON (42794-086-14) > 250 g in 1 BOTTLE |
| NDC Code | 42794-086-14 |
| Proprietary Name | Sodium Phenylbutyrate |
| Package Description | 1 BOTTLE in 1 CARTON (42794-086-14) > 250 g in 1 BOTTLE |
| Product NDC | 42794-086 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Sodium Phenylbutyrate |
| Dosage Form Name | POWDER |
| Route Name | ORAL |
| Start Marketing Date | 20130403 |
| Marketing Category Name | ANDA |
| Labeler Name | Sigmapharm Laboratories, LLC |
| Substance Name | SODIUM PHENYLBUTYRATE |
| Strength Number | .94 |
| Strength Unit | g/g |
| Pharmaceutical Classes | Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] |