Bisacodyl

Product NDC
0615-0598
11-digit product format
006150598
Labeler code
0615
Product ID
0615-0598_8f2fa151-2171-45dc-bd2a-6e7ae4248156
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl Enteric Coated
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1993-09-02
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-0598DDiscontinued by firm2026-08-07
excluded packagepackage0615-05980615-0598-39DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-0598-39DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-0598-39DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-0598-39DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-0598-39DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-0598-39DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-0598-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-0598-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-0598-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-0598-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-0598-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-0598-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-0598-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0615-0598-39IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0615-0598-39IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0615-0598-39IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0615-0598-39IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-0598-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-0598-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-0598-39EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-0598-392022-10-31C16284748780-19d75b9d0-2efc-f424-e053-dadaa90a57ceBisacodyl Enteric Coated Tablet
0615-0598-392020-01-31C16284748780-19d75b9d0-2efc-f424-e053-dadaa90a57ceBisacodyl Enteric Coated Tablet

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
ACACIAINACTIVE INGREDIENT5C5403N26OBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
CALCIUM SULFATE ANHYDROUSINACTIVE INGREDIENTE934B3V59HBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
GELATININACTIVE INGREDIENT2G86QN327LBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
SHELLACINACTIVE INGREDIENT46N107B71OBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
SUCROSEINACTIVE INGREDIENTC151H8M554BISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
TALCINACTIVE INGREDIENT7SEV7J4R1UBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBISACODYL (BISACODYL ENTERIC COATED) TABLET, COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]7