Home NDC 55566-9800 Rebyota
Product NDC 55566-9800
11-digit product format 555669800
Labeler code 55566
Product ID 55566-9800_2484fbb1-68f0-4bae-890e-8a208e5d3c7a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donor Human Stool
Dosage form SUSPENSION
Route RECTAL
Labeler Ferring Pharmaceuticals Inc.
Application BLA125739
Marketing category BLA
Marketing start 2023-01-09
Substance DONOR HUMAN STOOL
Active strength 50000000000 [CFU]/150mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Rebyota
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DONOR HUMAN STOOL 50000000000 [CFU]/150mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3TVP4E28JR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2626732 Internal RxNorm lookup 2626737 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55566-9800-0 Rebyota 150 mL in 1 BAG SUSPENSION 150 5 55566-9800-1 Rebyota 1 in 1 CARTON SUSPENSION 1 5 55566-9800-2 Rebyota 1 in 1 CARTON SUSPENSION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55566-9800 REBYOTA (DONOR HUMAN STOOL) SUSPENSION [FERRING PHARMACEUTICALS INC.] 5 Current NDC, 3 package rows 20241225_7af8a7f6-a441-4dc6-a151-138a89166fbb.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125739 Rebyota fecal microbiota, live-jslm 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2626732 fecal microbiota, live-jslm 150 ML Enema PSN 7af8a7f6-a441-4dc6-a151-138a89166fbb 5 2626737 REBYOTA 150 ML Enema PSN 7af8a7f6-a441-4dc6-a151-138a89166fbb 5 2626737 fecal microbiota, live-jslm 50000000000 UNT/ML Enema [Rebyota] SBD 7af8a7f6-a441-4dc6-a151-138a89166fbb 5 2626732 fecal microbiota, live-jslm 50000000000 UNT/ML Enema SCD 7af8a7f6-a441-4dc6-a151-138a89166fbb 5 2626732 fecal microbiota, live-jslm 50,000,000,000 UNT/ML per 150 ML Enema SY 7af8a7f6-a441-4dc6-a151-138a89166fbb 5 2626737 Rebyota 50,000,000,000 UNT/ML per 150 ML Enema SY 7af8a7f6-a441-4dc6-a151-138a89166fbb 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55566-9800-0 55566980000 150 mL in 1 BAG 150 ml Historical 55566-9800-1 55566980001 1 in 1 CARTON Historical 55566-9800-2 55566980002 1 CARTON in 1 CARTON (55566-9800-2) / 1 BAG in 1 CARTON (55566-9800-1) / 150 mL in 1 BAG (55566-9800-0) 1 carton 2023-01-09 No No Current