NDC 55566-9800-1 - Rebyota

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 55566-9800
Requested NDC: 55566-9800-1
Package NDCs from labels: 55566-9800-0, 55566-9800-1, 55566-9800-2
Manufacturer: Ferring Pharmaceuticals Inc.
Effective date: 2024-12-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Rebyota - Ferring Pharmaceuticals Inc.	Ferring Pharmaceuticals Inc.	2024-12-23	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-9800-0	ML - Milliliter	55566-9800	7833d6d6-11e9-42d7-bbcd-0481c8c49df5	1	2023-02-06
55566-9800-2	ML - Milliliter	55566-9800	86bd1cc5-c485-4743-849a-fa3e8aded7fd	1	2023-02-06

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rebyota	DONOR HUMAN STOOL	Ferring Pharmaceuticals Inc.	7af8a7f6-a441-4dc6-a151-138a89166fbb	2024-12-23	Warnings, Adverse reactions	Exact identifier application number: BLA125739 ndc (package): 55566-9800-1 ndc (package): 55566-9800-0 ndc (package): 55566-9800-2 ndc (product): 55566-9800 ndc11 (package): 55566980001 rxcui: 2626732 rxcui: 2626737 spl id: 2484fbb1-68f0-4bae-890e-8a208e5d3c7a spl set id: 7af8a7f6-a441-4dc6-a151-138a89166fbb unii: 3TVP4E28JR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.