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NDC 68462-0853-20 sodium phenylbutyrate 500 mg/1 Details
sodium phenylbutyrate 500 mg/1
sodium phenylbutyrate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GLENMARK PHARMACEUTICALS INC., USA. The primary component is SODIUM PHENYLBUTYRATE.
Product Information
| NDC | 68462-0853 |
|---|---|
| Product ID | 68462-853_2c63a7e3-94f0-4a60-9169-bd7665f1c131 |
| Associated GPIs | |
| 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 | Generic |
| Proprietary Name | sodium phenylbutyrate |
| 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 | GLENMARK PHARMACEUTICALS INC., USA |
| Pharmaceutical Class | Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216462 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 68462-0853-20 (68462085320)
| NDC Package Code | 68462-853-20 |
|---|---|
| Billing NDC | 68462085320 |
| Package | 250 TABLET in 1 BOTTLE (68462-853-20) |
| Marketing Start Date | 2022-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |