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NDC 75987-0060-08 BUPHENYL 500 mg/1 Details
BUPHENYL 500 mg/1
BUPHENYL is a ORAL TABLET 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 | 75987-0060 |
|---|---|
| Product ID | 75987-060_fc7c51c0-ed77-459c-8dad-aabeb9d863d2 |
| Associated GPIs | 30908060000320 |
| GCN Sequence Number | 026624 |
| GCN Sequence Number Description | sodium phenylbutyrate TABLET 500 MG ORAL |
| HIC3 | D9A |
| HIC3 Description | AMMONIA INHIBITORS |
| GCN | 43371 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| 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 | NDA020572 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75987-0060-08 (75987006008)
| NDC Package Code | 75987-060-08 |
|---|---|
| Billing NDC | 75987006008 |
| Package | 1 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE |
| Marketing Start Date | 1996-05-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |