OLPRUVA

Orange BookSPL

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

Identification

ManufacturerAcer Therapeutics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7254240018
90 BOX in 1 CARTON (72542-400-18) / 1 KIT in 1 BOX (72542-400-02) * 1 FOR SUSPENSION in 1 PACKET (72542-002-01) * 1 FOR SUSPENSION in 1 PACKET (72542-000-01)

Annotations

Orange Book

N214860

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "89abc31c-43e8-4809-9eb7-172cb31a86f1": {
      "match": "brand_token",
      "title": "OLPRUVA (SODIUM PHENYLBUTYRATE) KIT [ACER THERAPEUTICS INC.]",
      "spl_version": "4",
      "published_date": "2024-12-20"
    }
  },
  "productid": "72542-400_7720f74d-f161-4aaa-a421-7bf48e6c962c",
  "productndc": "72542-400",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214860",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2GM/PACKET",
        "product_no": "001",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3GM/PACKET",
        "product_no": "002",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4GM/PACKET",
        "product_no": "003",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5GM/PACKET",
        "product_no": "004",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6GM/PACKET",
        "product_no": "005",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6.67GM/PACKET",
        "product_no": "006",
        "approval_date": "Dec 22, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5GM/PACKET",
        "product_no": "007",
        "approval_date": "Oct 10, 2025"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM/PACKET",
        "product_no": "008",
        "approval_date": "Oct 10, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "OLPRUVA",
  "active_ingred_unit": null,
  "application_number": "NDA214860",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium phenylbutyrate",
  "start_marketing_date": "20221222",
  "active_numerator_strength": null
}

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