Home NDC 57896-443-05 Bisacodyl
Product NDC 57896-443
Requested package NDC 57896-443-05
11-digit product format 578960443
Labeler code 57896
Product ID 57896-443_41d6e645-b654-726f-e063-6394a90a101b
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form SUPPOSITORY
Route RECTAL
Labeler GERI-CARE PHARMACEUTICAL CORP
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-01
Substance BISACODYL
Active strength 10 mg/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 3 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57896-443 57896-443-05 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57896-443 57896-443-05 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57896-443 57896-443-05 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Additional Listing Data#
Finished product Yes
Brand name base Bisacodyl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISACODYL 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 10X0709Y6I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198509 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57896-443-01 Bisacodyl 20 in 1 CARTON SUPPOSITORY 20 6 57896-443-05 Bisacodyl 10 in 1 CARTON SUPPOSITORY 10 6 57896-443-12 Bisacodyl 2 in 1 CARTON SUPPOSITORY 2 6 57896-443-55 Bisacodyl 5 in 1 BLISTER PACK SUPPOSITORY 5 6 57896-443-66 Bisacodyl 6 in 1 BLISTER PACK SUPPOSITORY 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-443 BISACODYL SUPPOSITORY [GERI-CARE PHARMACEUTICAL CORP] 5 Current NDC, Legacy NDC, 5 package rows 20231031_a747a57a-028e-70ea-e053-2a95a90ac184.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.
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 57896-443-05 57896044305 10 BLISTER PACK in 1 CARTON (57896-443-05) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) 10 blister pack 2019-11-01 0000-00-00 No No Current