VOWST
- Product NDC
- 71881-400
- 11-digit product format
- 718810400
- Labeler code
- 71881
- Product ID
- 71881-400_cd143fac-e440-417f-bb29-f21b3f8526e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fecal microbiota spores, live-brpk
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aimmune Therapeutics, Inc.
- Application
- BLA125757
- Marketing category
- BLA
- Marketing start
- 2023-04-26
- Substance
- DONOR HUMAN STOOL SPORES (ETHANOL TREATED)
- Active strength
- 30000000 [CFU]/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VOWST
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONOR HUMAN STOOL SPORES (ETHANOL TREATED) | 30000000 [CFU]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9K7X6R5BMW |
| Rxcui | 2636542, 2636548 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71881-400-12 | VOWST | 1 in 1 CARTON | CAPSULE | 1 | | 5 |
| 71881-400-12 | VOWST | 12 in 1 BOTTLE | CAPSULE | 12 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71881-400 | VOWST (FECAL MICROBIOTA SPORES, LIVE-BRPK) CAPSULE [AIMMUNE THERAPEUTICS, INC.] | 4 | Current NDC, 2 package rows | 20250327_99e5a37a-930c-4641-bcdd-7013ec1c15fe.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2636542 | fecal microbiota spores, live-brpk 30,000,000 UNT Oral Capsule | PSN | 99e5a37a-930c-4641-bcdd-7013ec1c15fe | 5 |
| 2636548 | VOWST 30,000,000 UNT Oral Capsule | PSN | 99e5a37a-930c-4641-bcdd-7013ec1c15fe | 5 |
| 2636548 | fecal microbiota spores, live-brpk 30000000 UNT Oral Capsule [Vowst] | SBD | 99e5a37a-930c-4641-bcdd-7013ec1c15fe | 5 |
| 2636542 | fecal microbiota spores, live-brpk 30000000 UNT Oral Capsule | SCD | 99e5a37a-930c-4641-bcdd-7013ec1c15fe | 5 |
| 2636542 | fecal microbiota spores, live-brpk 30,000,000 UNT Oral Capsule | SY | 99e5a37a-930c-4641-bcdd-7013ec1c15fe | 5 |
| 2636548 | Vowst 30000000 UNT Oral Capsule | SY | 99e5a37a-930c-4641-bcdd-7013ec1c15fe | 5 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71881-400-12 | 71881040012 | 1 BOTTLE in 1 CARTON (71881-400-12) / 12 CAPSULE in 1 BOTTLE | 1 bottle | 2023-04-26 | No | No | Current |