Home NDC 68016-220 Premier Value
Product NDC 68016-220
11-digit product format 680160220
Labeler code 68016
Product ID 68016-220_4750bfce-9afe-4bc0-b533-a2a30f263255
Type HUMAN OTC DRUG
Nonproprietary name Calcium Polycarbophil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PHARMACY VALUE ALLIANCE, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-16
Substance CALCIUM POLYCARBOPHIL
Active strength 625 mg/1
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM POLYCARBOPHIL 625 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8F049NKY49 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308934 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 68016-220-25 Premier Value 250 in 1 BOTTLE TABLET, FILM COATED 250 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-220 PREMIER VALUE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241030_4d766548-00d0-41bd-bb58-b69e037c77e2.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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68016-220-25 68016022025 250 TABLET, FILM COATED in 1 BOTTLE (68016-220-25) 2019-04-16 0000-00-00 No No Current