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NDC 75987-0070-09 Buphenyl 0.94 g/g Details
Buphenyl 0.94 g/g
Buphenyl is a ORAL POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is SODIUM PHENYLBUTYRATE.
Product Information
| NDC | 75987-0070 |
|---|---|
| Product ID | 75987-070_fc7c51c0-ed77-459c-8dad-aabeb9d863d2 |
| Associated GPIs | 30908060002950 |
| GCN Sequence Number | 026631 |
| GCN Sequence Number Description | sodium phenylbutyrate POWDER 0.94 G/G ORAL |
| HIC3 | D9A |
| HIC3 Description | AMMONIA INHIBITORS |
| GCN | 43370 |
| HICL Sequence Number | 011317 |
| HICL Sequence Number Description | SODIUM PHENYLBUTYRATE |
| Brand/Generic | Brand |
| Proprietary Name | Buphenyl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium phenylbutyrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER |
| Route | ORAL |
| Active Ingredient Strength | 0.94 |
| Active Ingredient Units | g/g |
| Substance Name | SODIUM PHENYLBUTYRATE |
| Labeler Name | Horizon Therapeutics USA, Inc. |
| Pharmaceutical Class | Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020573 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75987-0070-09 (75987007009)
| NDC Package Code | 75987-070-09 |
|---|---|
| Billing NDC | 75987007009 |
| Package | 1 BOTTLE in 1 CARTON (75987-070-09) / 250 g in 1 BOTTLE |
| Marketing Start Date | 1996-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |