FDA.reportPublic FDA data

Bisacodyl

Product NDC
0904-7927
11-digit product format
009047927
Labeler code
0904
Product ID
0904-7927_ef59dfa9-6841-4df3-9167-4dffd9a8b7ce
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-10-24
Marketing end
2021-05-31
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7927-17EA - Each0904-79277e7907ab-0977-40ec-a77a-d6f395a894a212013-02-13
0904-7927-60EA - Each0904-79273e50c02d-9513-47d5-bea0-f898f04891a712013-02-13
0904-7927-61EA - Each0904-7927856c9c8d-f029-4cdd-b96c-8f84d822b28d12013-02-13
0904-7927-80EA - Each0904-792793f3c97b-baac-4a58-b9d9-3d7f4876bfc412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J0BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J0BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J0BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [CLINICAL SOLUTIONS WHOLESALE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL ENTERIC COATED (BISACODYL) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN458f701f-6f74-46c7-a801-6669cbf1b5b52
308753bisacodyl 5 MG Delayed Release Oral TabletPSNb4e052c0-d849-4327-a191-6d71d862886f2
308753bisacodyl 5 MG Delayed Release Oral TabletSCD458f701f-6f74-46c7-a801-6669cbf1b5b52
308753bisacodyl 5 MG Delayed Release Oral TabletSCDb4e052c0-d849-4327-a191-6d71d862886f2
308753bisacodyl 5 MG Enteric Coated Oral TabletSY458f701f-6f74-46c7-a801-6669cbf1b5b52
308753bisacodyl 5 MG Enteric Coated Oral TabletSYb4e052c0-d849-4327-a191-6d71d862886f2
308753bisacodyl 5 MG Delayed Release Oral TabletPSNf97e277d-2fb1-4fad-845a-a1d5541dad731
308753bisacodyl 5 MG Delayed Release Oral TabletSCDf97e277d-2fb1-4fad-845a-a1d5541dad731
308753bisacodyl 5 MG Enteric Coated Oral TabletSYf97e277d-2fb1-4fad-845a-a1d5541dad731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7927-6000904792760100 TABLET, COATED in 1 BOTTLE (0904-7927-60) 2008-10-242021-05-31NoNoCurrent
0904-7927-80009047927801000 TABLET, COATED in 1 BOTTLE (0904-7927-80) 2008-10-242021-05-31NoNoCurrent