FDA.reportPublic FDA data

ENTERIC COATED STIMULANT LAXATIVE

Product NDC
0536-3381
11-digit product format
005363381
Labeler code
0536
Product ID
0536-3381_aa7dc5af-9063-be48-e053-2995a90a8586
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RUGBY LABORATORIES INC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-09-22
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3381-01EA - Each0536-3381339543bc-2ebf-4d02-9bb3-f9f51845c86612012-07-24
0536-3381-10EA - Each0536-3381d63a3c8e-e182-4118-a7bf-efa95465b54812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
BISACODYLACTIVE MOIETY10X0709Y6IENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW3BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554ENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN8b890125-9cd4-427b-8a6e-0070a58cca621
308753bisacodyl 5 MG Delayed Release Oral TabletPSNc96e2eff-bd7e-4019-9826-c15bafe2e4061
308753bisacodyl 5 MG Delayed Release Oral TabletSCD8b890125-9cd4-427b-8a6e-0070a58cca621
308753bisacodyl 5 MG Delayed Release Oral TabletSCDc96e2eff-bd7e-4019-9826-c15bafe2e4061
308753bisacodyl 5 MG Enteric Coated Oral TabletSY8b890125-9cd4-427b-8a6e-0070a58cca621
308753bisacodyl 5 MG Enteric Coated Oral TabletSYc96e2eff-bd7e-4019-9826-c15bafe2e4061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-3381-0100536338101100 TABLET, DELAYED RELEASE in 1 BOX (0536-3381-01) 2012-09-220000-00-00NoNoCurrent
0536-3381-10005363381101000 TABLET, DELAYED RELEASE in 1 BOTTLE (0536-3381-10) 2012-09-220000-00-00NoNoCurrent