Home NDC 77333-120 FIBER LAXATIVE CAPLETS
Product NDC 77333-120
11-digit product format 773330120
Labeler code 77333
Product ID 77333-120_5d28c171-a408-24d4-e063-6294a90abe0c
Type HUMAN OTC DRUG
Nonproprietary name CALCIUM POLYCARBOPHIL
Dosage form TABLET
Route ORAL
Labeler Gendose Pharmaceuticals, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-02
Substance CALCIUM POLYCARBOPHIL
Active strength 625 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 77333-120 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 77333-120 77333-120-50 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 FIBER LAXATIVE CAPLETS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM POLYCARBOPHIL 625 mg/1
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77333-120-25 FIBER LAXATIVE CAPLETS 1 in 1 BLISTER PACK TABLET 1 6 77333-120-50 FIBER LAXATIVE CAPLETS 50 in 1 BOX TABLET 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77333-120 FIBER LAXATIVE CAPLETS (CALCIUM POLYCARBOPHIL) TABLET [GENDOSE PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240504_e7f3b91b-7942-3e0d-e053-2a95a90a34ee.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 Units Marketing start Marketing end Sample Exclude flag Status 77333-120-25 77333012025 1 in 1 BLISTER PACK Historical 77333-120-50 77333012050 50 BLISTER PACK in 1 BOX (77333-120-50) / 1 TABLET in 1 BLISTER PACK (77333-120-25) 50 blister pack 2022-09-02 0000-00-00 No No Current