rebyota

Generic: donor human stool

Labeler: ferring pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name rebyota
Generic Name donor human stool
Labeler ferring pharmaceuticals inc.
Dosage Form SUSPENSION
Routes
RECTAL
Active Ingredients

donor human stool 50000000000 [CFU]/150mL

Manufacturer
Ferring Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 55566-9800
Product ID 55566-9800_2484fbb1-68f0-4bae-890e-8a208e5d3c7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125739
Listing Expiration 2026-12-31
Marketing Start 2023-01-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 555669800
Hyphenated Format 55566-9800

Supplemental Identifiers

RxCUI
2626732 2626737
UNII
3TVP4E28JR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rebyota (source: ndc)
Generic Name donor human stool (source: ndc)
Application Number BLA125739 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 50000000000 [CFU]/150mL
source: ndc
Packaging
  • 1 CARTON in 1 CARTON (55566-9800-2) / 1 BAG in 1 CARTON (55566-9800-1) / 150 mL in 1 BAG (55566-9800-0)
source: ndc

Packages (1)

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

Ingredients (1)

donor human stool (50000000000 [CFU]/150mL)

Linked Drug Pages (1)

Rebyota ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "2484fbb1-68f0-4bae-890e-8a208e5d3c7a", "openfda": {"unii": ["3TVP4E28JR"], "rxcui": ["2626732", "2626737"], "spl_set_id": ["7af8a7f6-a441-4dc6-a151-138a89166fbb"], "manufacturer_name": ["Ferring Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 CARTON (55566-9800-2)  / 1 BAG in 1 CARTON (55566-9800-1)  / 150 mL in 1 BAG (55566-9800-0)", "package_ndc": "55566-9800-2", "marketing_start_date": "20230109"}], "brand_name": "Rebyota", "product_id": "55566-9800_2484fbb1-68f0-4bae-890e-8a208e5d3c7a", "dosage_form": "SUSPENSION", "product_ndc": "55566-9800", "generic_name": "Donor Human Stool", "labeler_name": "Ferring Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rebyota", "active_ingredients": [{"name": "DONOR HUMAN STOOL", "strength": "50000000000 [CFU]/150mL"}], "application_number": "BLA125739", "marketing_category": "BLA", "marketing_start_date": "20230109", "listing_expiration_date": "20261231"}