Prescription drug · BLA
Vowst NDC 71881-400
fecal microbiota spores, live-brpk · Donor human stool spores (Ethanol treated) 30000000 [CFU]/1 · Capsule · Oral · Aimmune Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71881-400-12 | 71881040012 | 1 BOTTLE in 1 CARTON (71881-400-12) / 12 CAPSULE in 1 BOTTLEMarketed from Apr 26, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Vowst
- Generic name (nonproprietary)
- fecal microbiota spores, live-brpk
- Active ingredients
- Donor human stool spores (Ethanol treated) — 30000000 [CFU]/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aimmune Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125757
- Marketing start
- Listing expires
- Identifiers
- Product ID 71881-400_cd143fac-e440-417f-bb29-f21b3f8526e5SPL ID cd143fac-e440-417f-bb29-f21b3f8526e5SPL set ID 99e5a37a-930c-4641-bcdd-7013ec1c15feRxCUI 2636542, 2636548UNII 9K7X6R5BMW
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471881040012followed by a unit qualifier and the quantityPackage 71881-0400-12. 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 .
Indications (excerpt from the label)
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). ( 1 ) Limitation of Use: VOWST is not indicated for treatment of CDI. Limitation of Use: VOWST is not indicated for treatment of CDI.
Excerpt only. Read the full label for complete information.