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 1 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cholestyramine powder for suspensionCHOLESTYRAMINE POWDER FOR SUSPENSIONBryant Ranch Prepack31d04422-f159-42ba-8eb5-b0ec1dbc52f92026-08-26Adverse reactionsExact identifier
unii: 4B33BGI082
cholestyramine powder for suspensionCHOLESTYRAMINE POWDER FOR SUSPENSIONBryant Ranch Prepack408ad775-9a1b-43cc-b122-226ade73e0c22026-08-25Adverse reactionsExact identifier
unii: 4B33BGI082
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
CholestyramineCHOLESTYRAMINEAiPing Pharmaceutical, Inc.214ea05f-de81-4026-9df9-4ce3820668ee2026-08-20Adverse reactionsExact identifier
unii: 4B33BGI082
cholestyramine powder for suspensionCHOLESTYRAMINE POWDER FOR SUSPENSIONBryant Ranch Prepack5238dc45-a2b7-4208-b1a7-cc695b6cd1f02026-08-10Adverse reactionsExact identifier
unii: 4B33BGI082
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
CholestyramineCHOLESTYRAMINEBryant Ranch Prepackcc447b99-e654-42dd-8cf1-f9e7952a25cd2026-07-16Warnings, Adverse reactionsExact identifier
unii: 4B33BGI082
CholestyramineCHOLESTYRAMINEBryant Ranch Prepackb26a13e9-42a2-4869-a00a-672bb1ac47422026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
CholestyramineCHOLESTYRAMINEBryant Ranch Prepack2998a314-deb2-4a02-afab-7e8c868888e22026-07-13Warnings, Adverse reactionsExact identifier
unii: 4B33BGI082
cholestyramine powder for suspensionCHOLESTYRAMINE POWDER FOR SUSPENSIONAscend Laboratories, LLC430ac07e-8524-4dec-a599-b7ebc56d95632026-07-10Adverse reactionsExact identifier
unii: 4B33BGI082
Choleystyramine LightCHOLEYSTYRAMINE LIGHTAscend Laboratories, LLC4c9d4561-d5b5-463b-ac57-1bc4d84d135d2026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
CholestyramineCHOLESTYRAMINEPar Health USA, LLCb0c65058-22c3-4f57-9b61-9bc6fcd6e2402026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
CHOLESTYRAMINECHOLESTYRAMINEEPIC PHARMA, LLCd02eca8c-18d4-4b11-bb16-08748543b04d2026-06-15Adverse reactionsExact identifier
unii: 4B33BGI082
CHOLESTYRAMINE LIGHTCHOLESTYRAMINE LIGHTEPIC PHARMA, LLC00990dec-7618-4cc8-9387-48c2cea8df1c2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082
MICOXASPERGILLUS NIGER VAR. NIGER - CANDIDA ALBICANS - CENTELLA ASIATICA - MALIC ACID - MERCURIC CHLORIDE - RHIZOPUS STOLONIFER - SODIUM DIETHYL OXALACETATE - SULFUR - TABEBUIA IMPETIGINOSA BARK -Guna spa790b50d3-8e1e-4c36-be74-f30c51ca78952026-06-11WarningsExact identifier
unii: 817L1N4CKP
GUNA-MATRIXASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE -Guna spafa9ed512-97dc-44a2-b32d-86ca8c2405322026-06-11WarningsExact identifier
unii: 817L1N4CKP
CHOLESTYRAMINECHOLESTYRAMINEZydus Pharmaceuticals (USA) Inc.acc48703-c15b-4275-aa75-749f1c07dcbb2026-04-28Adverse reactionsExact identifier
unii: 4B33BGI082
CHOLESTYRAMINECHOLESTYRAMINEZydus Lifesciences Limiteda86715e3-741f-47c6-9682-1413f0f8ff0c2026-04-28Adverse reactionsExact identifier
unii: 4B33BGI082
QUESTRANCHOLESTYRAMINEPar Health USA, LLC362ddd91-a63f-4ec6-841a-75785dd208c82026-04-17Warnings, Adverse reactionsExact identifier
rxcui: 1801279
unii: 4B33BGI082

Reported adverse events (FAERS/openFDA)#

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