FDA.reportPublic FDA data

Bisacodyl

Product NDC
71335-2010
11-digit product format
713352010
Labeler code
71335
Product ID
71335-2010_42ebd7ff-4d1b-4c81-9374-43cbef0dad3a
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2010-0Bisacodyl25 in 1 BOTTLETABLET, DELAYED RELEASE25104
71335-2010-1Bisacodyl30 in 1 BOTTLETABLET, DELAYED RELEASE30104
71335-2010-2Bisacodyl2 in 1 BOTTLETABLET, DELAYED RELEASE2104
71335-2010-3Bisacodyl3 in 1 BOTTLETABLET, DELAYED RELEASE3104
71335-2010-4Bisacodyl4 in 1 BOTTLETABLET, DELAYED RELEASE4104
71335-2010-5Bisacodyl10 in 1 BOTTLETABLET, DELAYED RELEASE10104
71335-2010-6Bisacodyl90 in 1 BOTTLETABLET, DELAYED RELEASE90104
71335-2010-7Bisacodyl8 in 1 BOTTLETABLET, DELAYED RELEASE8104
71335-2010-8Bisacodyl100 in 1 BOTTLETABLET, DELAYED RELEASE100104
71335-2010-9Bisacodyl20 in 1 BOTTLETABLET, DELAYED RELEASE20104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2010-4EA - Each71335-2010709a79ed-f4d2-4e5c-ae3e-0fcf2a20a8b012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2010BISACODYL TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20250402_71dea737-3fde-461f-958d-3a39ebdbf1ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Delayed Release Oral TabletSCD71dea737-3fde-461f-958d-3a39ebdbf1ae104
308753bisacodyl 5 MG Enteric Coated Oral TabletSY71dea737-3fde-461f-958d-3a39ebdbf1ae104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2010-07133520100025 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-0) 2024-04-030000-00-00NoNoCurrent
71335-2010-17133520100130 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-1) 2022-03-030000-00-00NoNoCurrent
71335-2010-2713352010022 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-2) 2024-04-030000-00-00NoNoCurrent
71335-2010-3713352010033 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-3) 2024-04-030000-00-00NoNoCurrent
71335-2010-4713352010044 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-4) 2022-01-030000-00-00NoNoCurrent
71335-2010-57133520100510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-5) 2022-01-180000-00-00NoNoCurrent
71335-2010-67133520100690 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-6) 2024-04-030000-00-00NoNoCurrent
71335-2010-7713352010078 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-7) 2022-01-120000-00-00NoNoCurrent
71335-2010-871335201008100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-8) 2024-04-030000-00-00NoNoCurrent
71335-2010-97133520100920 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2010-9) 2024-04-030000-00-00NoNoCurrent