NDC 43386-010 - GaviLyte-H and Bisacodyl

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
43386-010
Package NDCs from labels
43386-010-61
Manufacturer
Lupin Pharmaceuticals, Inc. | Novel Laboratories, Inc.
Effective date
2025-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bisacodyl - Lupin Pharmaceuticals, Inc. | Novel Laboratories, Inc.Lupin Pharmaceuticals, Inc. | Novel Laboratories, Inc.2025-01-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-010-61GaviLyte-H and Bisacodyl1 in 1 BLISTER PACKTABLET, DELAYED RELEASE15 mg3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-010GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.]3Unmatched20250130_78fe1c29-e22a-4615-a2f9-a61cd4eb38a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
BISACODYLACTIVE MOIETY10X0709Y6IGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CHERRYINACTIVE INGREDIENTBUC5I9595WGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
LEMONINACTIVE INGREDIENT24RS0A988OGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1

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 192 of 197 · 3,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA ALLERGYADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -Guna spaae6bd80d-2c70-1a3f-e053-2a95a90a26522020-10-23WarningsExact identifier
unii: 451W47IQ8X
GUNA MATRIX DETOXSODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS -Guna spaa369b95b-4d57-f149-e053-2995a90a87e32020-10-23Warnings, Adverse reactionsExact identifier
unii: ETJ7Z6XBU4
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SupremeABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEABOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE72c4679b-aa97-4888-9178-581d0f99c0b62020-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirstac0fd44a-3f39-8d7e-e053-2995a90afeec2020-08-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE AND POTASSIUM CHLORIDEB. Braun Medical Inc.e5bbb3e1-ab50-4ec7-a2b4-ce4091712e232020-07-31Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
CardioplegicCALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDEBaxter Healthcare Corporation1fd50ce5-2799-4c26-81da-02cf0578dd9e2020-06-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta62b71db-8ba2-6f6b-e053-2a95a90a29d12020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LACTATED RINGERS AND DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirsta62cf623-9b8a-37e0-e053-2995a90add5b2020-05-21Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Hay FeverAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENSNewton Laboratories, Inc.a6045b91-d361-2731-e053-2a95a90a97722020-05-18WarningsExact identifier
unii: 451W47IQ8X
DEXTROSE AND SODIUM CHLORIDEDEXTROSE MONOHYDRATE, SODIUM CHLORIDEFresenius Kabi USA, LLCb825c9c4-f2fb-4a4a-9d8c-fb020ad07e932020-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences Inc.23d818e7-c076-40de-8dc1-0b51ba4be96a2020-04-28Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDELupin Pharmaceuticals,Inc.1bbacdbb-91fa-4897-a00c-1b293de27b832020-04-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEMylan Pharmaceuticals Inc.c64ed4c0-1e27-42b3-9625-fb4e0d31e2712020-04-15Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2b8220f-e33a-51c3-e053-2995a90a07342020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta2bba76a-08ce-6902-e053-2995a90ab9c92020-04-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Electrolyte No. 48SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Companyb283a454-0c20-4fbf-92d3-dae1f3cd3cad2020-02-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationfbc01464-8885-4075-af41-911ffec5ae922020-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
POLYETHYLENE GLYCOL 3350 NFPOLYETHYLENE GLYCOL 3350SUNRISE PHARMACEUTICAL, INCce5197a1-2677-4ffb-aef2-9221b28ebd232020-01-22WarningsExact identifier
unii: G2M7P15E5P
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool VanillaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd701c221-9f68-47ff-b766-2f4f1998649f2019-10-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.