Rebyota

UNIISPL

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

Identification

ManufacturerFerring Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5556698002
1 CARTON in 1 CARTON (55566-9800-2) / 1 BAG in 1 CARTON (55566-9800-1) / 150 mL in 1 BAG (55566-9800-0)

Annotations

UNII (FDA Substance ID)

3TVP4E28JR

DONOR HUMAN STOOL

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3TVP4E28JR",
    "rxcui": null,
    "inchikey": null,
    "display_name": "DONOR HUMAN STOOL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RECTAL",
  "spl_meta": {
    "7af8a7f6-a441-4dc6-a151-138a89166fbb": {
      "match": "brand_token",
      "title": "REBYOTA (DONOR HUMAN STOOL) SUSPENSION [FERRING PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2024-12-25"
    }
  },
  "productid": "55566-9800_2484fbb1-68f0-4bae-890e-8a208e5d3c7a",
  "productndc": "55566-9800",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DONOR HUMAN STOOL",
  "proprietary_name": "Rebyota",
  "active_ingred_unit": "[CFU]/150mL",
  "application_number": "BLA125739",
  "marketing_category": "BLA",
  "nonproprietary_name": "Donor Human Stool",
  "start_marketing_date": "20230109",
  "active_numerator_strength": "50000000000"
}

Access this data programmatically

Query Rebyota 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.

Get a free API key Read the API docs