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NDC 55566-9800-02 Rebyota 50000000000 [CFU]/150mL Details
Rebyota 50000000000 [CFU]/150mL
Rebyota is a RECTAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is DONOR HUMAN STOOL.
Product Information
| NDC | 55566-9800 |
|---|---|
| Product ID | 55566-9800_80beb793-bf8c-4a85-96d7-46a0d270f4c7 |
| Associated GPIs | |
| GCN Sequence Number | 084129 |
| GCN Sequence Number Description | fecal microbiota, live-jslm ENEMA 150 ML RECTAL |
| HIC3 | D6P |
| HIC3 Description | FECAL MICROBIOTA TRANSPLANTATION (FMT) |
| GCN | 53279 |
| HICL Sequence Number | 048488 |
| HICL Sequence Number Description | FECAL MICROBIOTA, LIVE-JSLM |
| Brand/Generic | Brand |
| Proprietary Name | Rebyota |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Donor Human Stool |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | RECTAL |
| Active Ingredient Strength | 50000000000 |
| Active Ingredient Units | [CFU]/150mL |
| Substance Name | DONOR HUMAN STOOL |
| Labeler Name | Ferring Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125739 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55566-9800-02 (55566980002)
| NDC Package Code | 55566-9800-2 |
|---|---|
| Billing NDC | 55566980002 |
| Package | 1 CARTON in 1 CARTON (55566-9800-2) / 1 BAG in 1 CARTON (55566-9800-1) / 150 mL in 1 BAG (55566-9800-0) |
| Marketing Start Date | 2023-01-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |