FDA.reportPublic FDA data

STIMULANT LAXATIVE

Product NDC
49483-003
11-digit product format
494830003
Labeler code
49483
Product ID
49483-003_938bf8c5-6834-6362-e053-2995a90aa7e6
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-01
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
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-003-00STIMULANT LAXATIVE100000 in 1 CARTONTABLET, DELAYED RELEASE1000007
49483-003-01STIMULANT LAXATIVE100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1007
49483-003-10STIMULANT LAXATIVE1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10007
49483-003-52STIMULANT LAXATIVE25 in 1 BLISTER PACKTABLET, DELAYED RELEASE257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-003-01EA - Each49483-003215fe235-d140-48dc-b6c5-5c561fc7db5f12012-07-24
49483-003-10EA - Each49483-00312c91021-1f57-49ab-b336-737d5fc1931e12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6ISTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
BISACODYLACTIVE MOIETY10X0709Y6ISTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
ACACIAINACTIVE INGREDIENT5C5403N26OSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ESTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1USTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-003STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [TIME CAP LABORATORIES, INC.]7Current NDC, Legacy NDC, 4 package rows20191004_e0a9f8d9-660b-431c-8043-6d8ec81f98e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNe0a9f8d9-660b-431c-8043-6d8ec81f98e57
308753bisacodyl 5 MG Delayed Release Oral TabletSCDe0a9f8d9-660b-431c-8043-6d8ec81f98e57
308753bisacodyl 5 MG Enteric Coated Oral TabletSYe0a9f8d9-660b-431c-8043-6d8ec81f98e57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-003-0049483000300100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-003-00) 2018-12-070000-00-00NoNoCurrent
49483-003-0149483000301100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-01) 2018-12-070000-00-00NoNoCurrent
49483-003-10494830003101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10) 2018-12-070000-00-00NoNoCurrent
49483-003-524948300035225 TABLET, DELAYED RELEASE in 1 BLISTER PACK (49483-003-52) 2018-12-070000-00-00NoNoCurrent