stimulant laxative enteric coated

Product NDC
71610-453
11-digit product format
716100453
Labeler code
71610
Product ID
71610-453_2b4c7710-ccef-da92-e063-6394a90a5416
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
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
stimulant laxative enteric coated
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
71610-453-02stimulant laxative enteric coated2 in 1 BOTTLETABLET24
71610-453-04stimulant laxative enteric coated4 in 1 BOTTLETABLET44
71610-453-20stimulant laxative enteric coated20 in 1 BOTTLETABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-453-20EA - Each71610-4538e114329-7737-412c-92aa-432d3135030212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-453STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 3 package rows20250112_0331c762-d318-48d6-97ed-86499c6c8b30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN0331c762-d318-48d6-97ed-86499c6c8b304
308753bisacodyl 5 MG Delayed Release Oral TabletSCD0331c762-d318-48d6-97ed-86499c6c8b304
308753bisacodyl 5 MG Enteric Coated Oral TabletSY0331c762-d318-48d6-97ed-86499c6c8b304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-453-02716100453022 TABLET in 1 BOTTLE (71610-453-02) 2 tablet2020-08-280000-00-00NoNoCurrent
71610-453-04716100453044 TABLET in 1 BOTTLE (71610-453-04) 4 tablet2020-07-310000-00-00NoNoCurrent
71610-453-207161004532020 TABLET in 1 BOTTLE (71610-453-20) 20 tablet2021-09-200000-00-00NoNoCurrent