FDA.reportPublic FDA data

Bisacodyl

Product NDC
68016-688
11-digit product format
680160688
Labeler code
68016
Product ID
68016-688_12bba10e-970d-443e-93fe-796395cc7093
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisacodyl

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
68016-688-10Bisacodyl1 in 1 CARTONTABLET, DELAYED RELEASE115
68016-688-10Bisacodyl100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10015
68016-688-25Bisacodyl25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2515
68016-688-25Bisacodyl1 in 1 CARTONTABLET, DELAYED RELEASE115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-688-10EA - Each68016-688c126788f-a50c-499b-a339-fa4039c0be9712022-06-06
68016-688-25EA - Each68016-6887c9c90b5-0d17-4c0a-ab7a-bb12893e3a8212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BISACODYL TABLET [CHAIN DRUG CONSORTIUM]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBISACODYL TABLET [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-688BISACODYL TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM]14Current NDC, Legacy NDC, 4 package rows20250428_71215710-f33d-4e01-a543-fc46b5ce5137.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN71215710-f33d-4e01-a543-fc46b5ce513715
308753bisacodyl 5 MG Delayed Release Oral TabletSCD71215710-f33d-4e01-a543-fc46b5ce513715
308753bisacodyl 5 MG Enteric Coated Oral TabletSY71215710-f33d-4e01-a543-fc46b5ce513715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-688-10680160688101 BOTTLE, PLASTIC in 1 CARTON (68016-688-10) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2002-03-252027-01-31NoNoCurrent
68016-688-25680160688251 BLISTER PACK in 1 CARTON (68016-688-25) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2002-03-252027-01-31NoNoCurrent