Back to search
🇺🇸

United States · US · US:72786-111_e27a3e07-438e-49d3-aae3-095e9379c7b4

OXBRYTA

Orange BookUNIISPLATC B06AX03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGlobal Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeB06AX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7278611102
    60 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-02)
  • ndc11
    7278611103
    90 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-03)

Annotations

UNII (FDA Substance ID)
3ZO554A4Q8
VOXELOTOR
RxCUI 2265678
Orange Book
N216157
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3ZO554A4Q8",
    "rxcui": "2265678",
    "inchikey": "FWCVZAQENIZVMY-UHFFFAOYSA-N",
    "display_name": "VOXELOTOR",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3c557fac-29ec-483f-b691-8a935d4decc3": {
      "match": "brand_token",
      "title": "OXBRYTA (VOXELOTOR) TABLET, FILM COATED OXBRYTA (VOXELOTOR) TABLET, FOR SUSPENSION [GLOBAL BLOOD THERAPEUTICS, INC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "13",
      "published_date": "2023-12-27"
    }
  },
  "productid": "72786-111_e27a3e07-438e-49d3-aae3-095e9379c7b4",
  "productndc": "72786-111",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "216157",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VOXELOTOR",
  "proprietary_name": "OXBRYTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216157",
  "marketing_category": "NDA",
  "nonproprietary_name": "Voxelotor",
  "start_marketing_date": "20211217",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code B06AX03.

Access this data programmatically

Query OXBRYTA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.