PHEBURANE

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMedunik USA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7177020010
1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10)

Annotations

Orange Book

N216513

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9": {
      "match": "brand_token",
      "title": "PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA]",
      "spl_version": "6",
      "published_date": "2025-11-28"
    }
  },
  "productid": "71770-200_4072f3df-e754-4c2e-be0c-af3c8edb9211",
  "productndc": "71770-200",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "216513",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "84GM/BOT",
        "product_no": "001",
        "approval_date": "Jun 17, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "PHEBURANE",
  "active_ingred_unit": null,
  "application_number": "NDA216513",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium phenylbutyrate",
  "start_marketing_date": "20220826",
  "active_numerator_strength": null
}

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