vowst

Generic: fecal microbiota spores, live-brpk

Labeler: aimmune therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name vowst
Generic Name fecal microbiota spores, live-brpk
Labeler aimmune therapeutics, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

donor human stool spores (ethanol treated) 30000000 [CFU]/1

Manufacturer
Aimmune Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 71881-400
Product ID 71881-400_b4fff30d-25fe-4b44-aff2-cd02cc251a1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125757
Listing Expiration 2026-12-31
Marketing Start 2023-04-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71881400
Hyphenated Format 71881-400

Supplemental Identifiers

RxCUI
2636542 2636548
UNII
9K7X6R5BMW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vowst (source: ndc)
Generic Name fecal microbiota spores, live-brpk (source: ndc)
Application Number BLA125757 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30000000 [CFU]/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71881-400-12) / 12 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

71881-400-12 1 BOTTLE in 1 CARTON (71881-400-12) / 12 CAPSULE in 1 BOTTLE

Ingredients (1)

donor human stool spores (ethanol treated) (30000000 [CFU]/1)

Linked Drug Pages (1)

VOWST ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4fff30d-25fe-4b44-aff2-cd02cc251a1c", "openfda": {"unii": ["9K7X6R5BMW"], "rxcui": ["2636542", "2636548"], "spl_set_id": ["99e5a37a-930c-4641-bcdd-7013ec1c15fe"], "manufacturer_name": ["Aimmune Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71881-400-12)  / 12 CAPSULE in 1 BOTTLE", "package_ndc": "71881-400-12", "marketing_start_date": "20230426"}], "brand_name": "VOWST", "product_id": "71881-400_b4fff30d-25fe-4b44-aff2-cd02cc251a1c", "dosage_form": "CAPSULE", "product_ndc": "71881-400", "generic_name": "fecal microbiota spores, live-brpk", "labeler_name": "Aimmune Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VOWST", "active_ingredients": [{"name": "DONOR HUMAN STOOL SPORES (ETHANOL TREATED)", "strength": "30000000 [CFU]/1"}], "application_number": "BLA125757", "marketing_category": "BLA", "marketing_start_date": "20230426", "listing_expiration_date": "20261231"}