What is NDC 55566-9800?

55566-9800 is the product NDC for Rebyota (donor human stool), Donor human stool 50000000000 [CFU]/150mL suspension, listed with the FDA by Ferring Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Ferring Pharmaceuticals Inc., NDC labeler code 55566. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rebyota?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rebyota NDC 55566-9800 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55566-9800Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55566-9800Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
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)Marketed from Jan 9, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Rebyota
Generic name (nonproprietary): donor human stool
Active ingredients: Donor human stool — 50000000000 [CFU]/150mL
Dosage form: Suspension
Route: Rectal
Labeler: Ferring Pharmaceuticals Inc.NDC labeler code 55566
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125739
Marketing start: Jan 9, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 55566-9800_2484fbb1-68f0-4bae-890e-8a208e5d3c7aSPL ID 2484fbb1-68f0-4bae-890e-8a208e5d3c7aSPL set ID 7af8a7f6-a441-4dc6-a151-138a89166fbbRxCUI 2626732, 2626737UNII 3TVP4E28JR

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N455566980002 followed by a unit qualifier and the quantity

Package 55566-9800-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 23, 2024.

Indications (excerpt from the label)

REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI. REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. ( 1 ) Limitation of Use: REBYOTA is not indicated for treatment of CDI. Limitation of Use: REBYOTA is not indicated for treatment of CDI.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55566-9800

What is NDC 55566-9800?: 55566-9800 is the product NDC for Rebyota (donor human stool), Donor human stool 50000000000 [CFU]/150mL suspension, listed with the FDA by Ferring Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rebyota (Donor Human Stool).
What is the active ingredient?: Donor human stool.
Who is the labeler?: Ferring Pharmaceuticals Inc., NDC labeler code 55566. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rebyota?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Rebyota (Donor human stool) NDC 55566-9800