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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3TVP4E28JR |
| Rxcui | 2626732, 2626737 |
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 |
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 | Historical |