FDA.reportPublic FDA data

Bisacodyl

Product NDC
0904-6407
11-digit product format
009046407
Labeler code
0904
Product ID
0904-6407_e4f6f4a5-584f-41fc-a279-a0cb3474c2e9
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisacodyl
Listing expiration
2027-12-31

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
0904-6407-61Bisacodyl10 in 1 BOXTABLET, DELAYED RELEASE1020
0904-6407-61Bisacodyl10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6407-61EA - Each0904-64073b250383-94aa-420e-b830-fbafc8fd3f1312015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
BISACODYLACTIVE MOIETY10X0709Y6IUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
ACACIAINACTIVE INGREDIENT5C5403N26OUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
SHELLACINACTIVE INGREDIENT46N107B71OUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
SUCROSEINACTIVE INGREDIENTC151H8M554UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
TALCINACTIVE INGREDIENT7SEV7J4R1UUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
TRIACETININACTIVE INGREDIENTXHX3C3X673UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH]2
BISACODYLACTIVE INGREDIENT10X0709Y6IUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
BISACODYLACTIVE MOIETY10X0709Y6IUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
ACACIAINACTIVE INGREDIENT5C5403N26OUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
SUCROSEINACTIVE INGREDIENTC151H8M554UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMUNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6407UNIT DOSE BISACODYL (BISACODYL) TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]17Current NDC, Legacy NDC, 2 package rows20241109_4fb4e630-875f-4c82-86d9-7696857e3c42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN4fb4e630-875f-4c82-86d9-7696857e3c4220
308753bisacodyl 5 MG Delayed Release Oral TabletSCD4fb4e630-875f-4c82-86d9-7696857e3c4220
308753bisacodyl 5 MG Enteric Coated Oral TabletSY4fb4e630-875f-4c82-86d9-7696857e3c4220
308753bisacodyl 5 MG Delayed Release Oral TabletPSN49cb9a34-4c76-48c5-92c0-39e0ffc805c316
308753bisacodyl 5 MG Delayed Release Oral TabletSCD49cb9a34-4c76-48c5-92c0-39e0ffc805c316
308753bisacodyl 5 MG Enteric Coated Oral TabletSY49cb9a34-4c76-48c5-92c0-39e0ffc805c316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6407-610090464076110 BLISTER PACK in 1 BOX (0904-6407-61) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2002-03-250000-00-00NoNoCurrent