Bisacodyl

Product NDC
57896-443
11-digit product format
578960443
Labeler code
57896
Product ID
57896-443_41d6e645-b654-726f-e063-6394a90a101b
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
GERI-CARE PHARMACEUTICAL CORP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
BISACODYL
Active strength
10 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
Bisacodyl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii10X0709Y6I
Rxcui198509

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-443-01Bisacodyl20 in 1 CARTONSUPPOSITORY206
57896-443-05Bisacodyl10 in 1 CARTONSUPPOSITORY106
57896-443-12Bisacodyl2 in 1 CARTONSUPPOSITORY26
57896-443-55Bisacodyl5 in 1 BLISTER PACKSUPPOSITORY56
57896-443-66Bisacodyl6 in 1 BLISTER PACKSUPPOSITORY66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-443-05EA - Each57896-44341c7bf1c-6922-4f95-9b3a-d556aaef79c412020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-443BISACODYL SUPPOSITORY [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 5 package rows20231031_a747a57a-028e-70ea-e053-2a95a90ac184.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSNa747a57a-028e-70ea-e053-2a95a90ac1846
198509bisacodyl 10 MG Rectal SuppositorySCDa747a57a-028e-70ea-e053-2a95a90ac1846
198509bisacodyl 10 MG Rectal SuppositoryPSNa199ea53-20b3-4aae-a3f4-265b50c96de51
198509bisacodyl 10 MG Rectal SuppositorySCDa199ea53-20b3-4aae-a3f4-265b50c96de51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-443-015789604430120 BLISTER PACK in 1 CARTON (57896-443-01) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) 20 blister pack2019-11-010000-00-00NoNoCurrent
57896-443-055789604430510 BLISTER PACK in 1 CARTON (57896-443-05) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) 10 blister pack2019-11-010000-00-00NoNoCurrent
57896-443-12578960443122 BLISTER PACK in 1 CARTON (57896-443-12) / 6 SUPPOSITORY in 1 BLISTER PACK (57896-443-66) 2 blister pack2019-11-010000-00-00NoNoCurrent
57896-443-55578960443555 in 1 BLISTER PACKHistorical
57896-443-66578960443666 in 1 BLISTER PACKHistorical