Bisacodyl

Product NDC
11534-013
11-digit product format
115340013
Labeler code
11534
Product ID
11534-013_6be65bdd-e94a-4682-9977-043741174c59
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sunrise Pharmaceutical Inc
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-07-08
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
5 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11534-013-012019-10-29C16284748780-1960f7f55-da9c-8e05-e053-dbdaa90a074aBisacodyl USP 5 mg Laxative
11534-013-032019-10-29C16284748780-1960f7f55-da9c-8e05-e053-dbdaa90a074aBisacodyl USP 5 mg Laxative
11534-013-252019-10-29C16284748780-1960f7f55-da9c-8e05-e053-dbdaa90a074aBisacodyl USP 5 mg Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11534-013-01Bisacodyl100 in 1 BOTTLETABLET, DELAYED RELEASE1003
11534-013-03Bisacodyl1000 in 1 BOTTLETABLET, DELAYED RELEASE10003
11534-013-25Bisacodyl25 in 1 BOTTLETABLET, DELAYED RELEASE253

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
KAOLININACTIVE INGREDIENT24H4NWX5COBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-013BISACODYL TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL INC]3Legacy NDC, 3 package rows20110815_d497e5a6-625a-49cb-bccb-a5e7da89b451.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSNd497e5a6-625a-49cb-bccb-a5e7da89b4513
308753bisacodyl 5 MG Delayed Release Oral TabletSCDd497e5a6-625a-49cb-bccb-a5e7da89b4513
308753bisacodyl 5 MG Enteric Coated Oral TabletSYd497e5a6-625a-49cb-bccb-a5e7da89b4513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11534-013-0111534001301100 in 1 BOTTLEHistorical
11534-013-03115340013031000 in 1 BOTTLEHistorical
11534-013-251153400132525 in 1 BOTTLEHistorical