FDA.reportPublic FDA data

NDC 0245-0036-89 - Prevalite

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
0245-0036
Requested NDC
0245-0036-89
Package NDCs from labels
0245-0036-89, 0245-0036-42, 0245-0036-60, 0245-0036-23
Manufacturer
Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc
Effective date
2025-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prevalite - Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, IncUpsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc2025-12-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0245-0036-23Prevalite231 g in 1 CANPOWDER, FOR SUSPENSION2319
0245-0036-42Prevalite42 in 1 CARTONPOWDER, FOR SUSPENSION429
0245-0036-60Prevalite60 in 1 CARTONPOWDER, FOR SUSPENSION609
0245-0036-89Prevalite5.5 g in 1 PACKETPOWDER, FOR SUSPENSION5.59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0036PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]7Current NDC, Legacy NDC, 4 package rows20200715_dd434ef8-8af3-434c-a0a0-9a0b18459ba0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0036-23GM - Gram0245-003647b55f59-1753-442d-81ab-a97a616cc03812012-07-24
0245-0036-42EA - Each0245-003619ba90aa-385b-4756-ba6c-18e173ceb77812012-07-24
0245-0036-60EA - Each0245-0036cb24fc51-b13a-43a8-a483-6ffec095374212012-07-24
0245-0036-89EA - Each0245-0036d8a155cb-f5d7-4880-8132-88988d81c79b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cholestyramineACTIVE INGREDIENT4B33BGI082PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4
cholestyramineACTIVE MOIETY4B33BGI082PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4
aspartameINACTIVE INGREDIENTZ0H242BBR1PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4
malic acidINACTIVE INGREDIENT817L1N4CKPPREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4
propylene glycol alginateINACTIVE INGREDIENT26CD3J2R0CPREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, INC.]4

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 2 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CholestyramineCHOLESTYRAMINEMicro Labs Limited09420793-7357-4194-8172-0b1cddb167fe2026-03-05Adverse reactionsExact identifier
unii: 4B33BGI082
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: 817L1N4CKP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: 817L1N4CKP
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: Z0H242BBR1
Arsenicum Combination 9251ARSENICUM COMBINATIONProfessional Complementary Health Formulasc52598b3-7100-4410-a4cb-b3dcacf445d72026-01-08WarningsExact identifier
unii: 817L1N4CKP
Thyroid Nosode Combination 9420THYROID NOSODE COMBINATIONProfessional Complementary Health Formulasf107e47e-4176-411f-83ac-bb2d0096b3b32026-01-08WarningsExact identifier
unii: 817L1N4CKP
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: Z0H242BBR1
CHOLESTYRAMINE LIGHTCHOLESTYRAMINE LIGHTEPIC PHARMA, LLC3899f0e0-988b-45dc-8ebd-a04330e75ee32025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
CHOLESTYRAMINECHOLESTYRAMINEEPIC PHARMA, LLCd931e372-2477-4554-912e-9d4d7d538ce22025-12-17Adverse reactionsExact identifier
unii: 4B33BGI082
CHOLESTYRAMINE LIGHTCHOLESTYRAMINE LIGHTEPIC PHARMA, LLCf8740b85-75f9-4e00-a8d3-7175298f17242025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
CHOLESTYRAMINECHOLESTYRAMINEEPIC PHARMA, LLCc65e556a-3b6a-4466-a7ce-5b24103ed8ad2025-12-17Adverse reactionsExact identifier
unii: 4B33BGI082
CHOLESTYRAMINECHOLESTYRAMINEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSd82647da-465b-4e2e-8cf8-72d50f047b3e2025-12-11Adverse reactionsExact identifier
unii: 4B33BGI082
CHOLESTYRAMINE LIGHTCHOLESTYRAMINE LIGHTPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS31655681-125c-4eaa-959b-8f434bb435902025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
CholestyramineCHOLESTYRAMINEMacleods Pharmaceuticals Limited8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b2025-12-09Adverse reactionsExact identifier
unii: 4B33BGI082
PrevaliteCHOLESTYRAMINEUpsher-Smith Laboratories, LLCdd434ef8-8af3-434c-a0a0-9a0b18459ba02025-12-02Warnings, Adverse reactionsExact identifier
application number: ANDA073263
ndc (package): 0245-0036-23
ndc (package): 0245-0036-42
ndc (package): 0245-0036-89
ndc (package): 0245-0036-60
ndc (product): 0245-0036
ndc11 (package): 00245003689
rxcui: 1801279
rxcui: 848951
spl id: 44feb603-0970-9b63-e063-6294a90a7ce5
spl set id: dd434ef8-8af3-434c-a0a0-9a0b18459ba0
unii: 4B33BGI082
CholestyramineCHOLESTYRAMINEAjanta Pharma USA Inc.a0b64dfe-49bc-45d7-9281-9e9d6e296c402025-10-08Adverse reactionsExact identifier
unii: 4B33BGI082
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: 817L1N4CKP
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: 817L1N4CKP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z0H242BBR1

Reported adverse events (FAERS/openFDA)#

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