Home NDC 0904-6407 Bisacodyl
Product NDC 0904-6407
11-digit product format 009046407
Labeler code 0904
Product ID 0904-6407_e4f6f4a5-584f-41fc-a279-a0cb3474c2e9
Type HUMAN OTC DRUG
Nonproprietary name Bisacodyl
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Major Pharmaceuticals
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2002-03-25
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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Bisacodyl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISACODYL 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 10X0709Y6I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-6407-61 Bisacodyl 10 in 1 BOX TABLET, DELAYED RELEASE 10 20 0904-6407-61 Bisacodyl 10 in 1 BLISTER PACK TABLET, DELAYED RELEASE 10 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BISACODYL ACTIVE INGREDIENT 10X0709Y6I UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 BISACODYL ACTIVE MOIETY 10X0709Y6I UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 Polyvinyl Acetate Phthalate INACTIVE INGREDIENT 58QVG85GW3 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [CARDINAL HEALTH] 2 BISACODYL ACTIVE INGREDIENT 10X0709Y6I UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 BISACODYL ACTIVE MOIETY 10X0709Y6I UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 Polyvinyl Acetate Phthalate INACTIVE INGREDIENT 58QVG85GW3 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM UNIT DOSE BISACODYL (BISACODYL) TABLET, COATED [MAJOR PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6407 UNIT DOSE BISACODYL (BISACODYL) TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 17 Current NDC, Legacy NDC, 2 package rows 20241109_4fb4e630-875f-4c82-86d9-7696857e3c42.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6407-61 00904640761 10 BLISTER PACK in 1 BOX (0904-6407-61) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK 10 blister pack 2002-03-25 0000-00-00 No No Current