Bisacodyl

Product NDC
16103-367
11-digit product format
161030367
Labeler code
16103
Product ID
16103-367_a86fbc38-1f71-4abc-aade-e98304763076
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Pharbest Pharmaceuticals Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-01-25
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-367-082020-01-31C16284748780-19d75b9cf-f26f-f424-e053-dadaa90a57ceDrug facts
16103-367-172020-01-31C16284748780-19d75b9cf-f26f-f424-e053-dadaa90a57ceDrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-367-08Bisacodyl100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1001
16103-367-17Bisacodyl25 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-367-08EA - Each16103-3675d324daa-f273-4129-97c0-6c278fe83acc12012-07-24
16103-367-17EA - Each16103-367cd0f35b3-1f82-4b2f-a273-010cce32a7be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-367BISACODYL TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20120625_29156c82-bb48-4356-860c-ca0e9001882e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN29156c82-bb48-4356-860c-ca0e9001882e1
308753bisacodyl 5 MG Delayed Release Oral TabletSCD29156c82-bb48-4356-860c-ca0e9001882e1
308753bisacodyl 5 MG Enteric Coated Oral TabletSY29156c82-bb48-4356-860c-ca0e9001882e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
16103-367-0816103036708100 in 1 BOTTLE, PLASTICHistorical
16103-367-171610303671725 in 1 BOTTLE, PLASTICHistorical