Home NDC 68016-513 Premier Value Fiber Therapy
Product NDC 68016-513
11-digit product format 680160513
Labeler code 68016
Product ID 68016-513_ffd14b1b-f6f2-42d7-8786-9ae0e72d7918
Type HUMAN OTC DRUG
Nonproprietary name Psyllium Husk
Dosage form POWDER
Route ORAL
Labeler PHARMACY VALUE ALLIANCE, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-18
Substance PSYLLIUM HUSK
Active strength 3.4 g/12g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Premier Value Fiber Therapy
Brand name suffix Orange Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSYLLIUM HUSK 3.4 g/12g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0SHO53407G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 824586 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 68016-513-72 Premier Value Fiber TherapyOrange Flavor 861 g in 1 BOTTLE POWDER 861 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-513 PREMIER VALUE FIBER THERAPY ORANGE FLAVOR (PSYLLIUM HUSK) POWDER [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241030_85651bd7-e959-4455-a5ed-bd0223ce0563.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 30 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-513-72 68016051372 861 g in 1 BOTTLE (68016-513-72) 861 g 2019-04-18 0000-00-00 No No Current