Home NDC 71881-400 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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9K7X6R5BMW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2636542 Internal RxNorm lookup 2636548 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VOWST FECAL MICROBIOTA SPORES, LIVE-BRPK Aimmune Therapeutics, Inc. 99e5a37a-930c-4641-bcdd-7013ec1c15fe 2026-04-23 Warnings, Adverse reactions Exact identifier application number: BLA125757 ndc (product): 71881-400
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125757 Vowst fecal microbiota spores, live-brpk 351(a) Rx 2026-07-01
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