FDA.reportPublic FDA data

Bisacodyl

Product NDC
71610-700
11-digit product format
716100700
Labeler code
71610
Product ID
71610-700_2b5b56c7-3f95-8a1c-e063-6394a90a4162
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
Substance
BISACODYL
Active strength
5 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

Additional Listing Data#

Finished product
Yes
Brand name base
Bisacodyl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui308753

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-700-02Bisacodyl2 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE22
71610-700-03Bisacodyl3 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE32
71610-700-04Bisacodyl4 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE42
71610-700-06Bisacodyl6 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE62
71610-700-08Bisacodyl8 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE82
71610-700-20Bisacodyl20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-700-06EA - Each71610-700366fed93-b266-4eb3-af6e-ccd191a94f2a12024-01-04
71610-700-08EA - Each71610-7003d292544-9058-40b6-8cf3-911b75d4a41512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-700BISACODYL TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 6 package rows20250112_ca67d5e8-d67d-44ce-adf7-cf9b2eed89d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNca67d5e8-d67d-44ce-adf7-cf9b2eed89d22
308753bisacodyl 5 MG Delayed Release Oral TabletSCDca67d5e8-d67d-44ce-adf7-cf9b2eed89d22
308753bisacodyl 5 MG Enteric Coated Oral TabletSYca67d5e8-d67d-44ce-adf7-cf9b2eed89d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-700-02716100700022 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-02) 2023-04-03NoNoHistorical
71610-700-03716100700033 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-03) 2023-04-03NoNoHistorical
71610-700-04716100700044 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-04) 2023-04-03NoNoHistorical
71610-700-06716100700066 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-06) 2023-04-03NoNoHistorical
71610-700-08716100700088 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-08) 2023-04-03NoNoHistorical
71610-700-207161007002020 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71610-700-20) 2023-04-03NoNoHistorical