FDA.reportPublic FDA data

carbinoxamine maleate 4 MG Oral Tablet

RxCUI
1012904
RxNorm name
carbinoxamine maleate 4 MG Oral Tablet
Display name
Carbinoxamine (Oral Pill)
Full name
carbinoxamine maleate 4 MG Oral Tablet
Term type
SCD
Status
Active
Strength
4 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-11-06 11:35:51

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
carbinoxamine maleate4 MG / 1 EACHcarbinoxaminecarbinoxamine maleate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
carbinoxamine20220

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRcarbinoxamine maleate 4 MG Oral Tablet1NAMES
RxNorm Namecarbinoxamine maleate 4 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10129041CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
44523-825-0144523-825Carbinoxamine Maleate Carbinoxamine MaleateBiocomp Pharma, Inc.ANDA090756
64950-211-0164950-211Carbinoxamine Maleate Carbinoxamine MaleateGenus Lifesciences Inc.ANDA040442

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA09075644523-825Carbinoxamine Maleate Carbinoxamine MaleateANDABiocomp Pharma, Inc.
ANDA04044264950-211Carbinoxamine Maleate Carbinoxamine MaleateANDAGenus Lifesciences Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 18 matching rows.

NDC11, Source, Active table
NDC11SourceActive
15310010904rxnav_ndcsyes
44523082501rxnav_ndcsyes
51991033301rxnav_ndcsyes
64950021101rxnav_ndcsyes
00045014260rxnav_historical
00525674801rxnav_historical_indirect
00525674804rxnav_historical_indirect
00525674805rxnav_historical_indirect
15310010901rxnav_historical
18011067401rxnav_historical
46672019110rxnav_historical
46672019124rxnav_historical
46672019150rxnav_historical
54868514900rxnav_historical_indirect
54868514901rxnav_historical_indirect
58716078501rxnav_historical
60258087001rxnav_historical
64376060501rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carbinoxamine MaleateCARBINOXAMINE MALEATEBiocomp Pharma, Inc.14266e97-674b-b6a9-37a2-a955f0a01c4f2025-12-17Warnings, Adverse reactionsExact identifier
ndc (package): 44523-825-01
ndc (product): 44523-825
ndc11 (package): 44523082501
rxcui: 1012904
Carbinoxamine MaleateCARBINOXAMINE MALEATEGenus Lifesciences Inc.9d11b197-cfdc-4b9b-9935-2920ccb6e5222024-03-06Warnings, Adverse reactionsExact identifier
ndc (package): 64950-211-01
ndc (product): 64950-211
ndc11 (package): 64950021101
rxcui: 1012904

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
14266e97-674b-b6a9-37a2-a955f0a01c4fcarbinoxamine maleate 4 MG Oral Tablet [PSN] · carbinoxamine maleate 4 MG Oral Tablet [SCD]28Carbinoxamine Maleate Tablets, USP 4 mg20251217
9d11b197-cfdc-4b9b-9935-2920ccb6e522carbinoxamine maleate 4 MG Oral Tablet [PSN] · carbinoxamine maleate 4 MG Oral Tablet [SCD]26Carbinoxamine Maleate Tablets, USP 4 mg Carbinoxamine Maleate Oral Solution, 4 mg/5 mL20240306

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
14266e97-674b-b6a9-37a2-a955f0a01c4fCarbinoxamine Maleate Tablets, USP 4 mgBiocomp Pharma, Inc. | Mission Pharmacal Company20251217
9d11b197-cfdc-4b9b-9935-2920ccb6e522Carbinoxamine Maleate Tablets, USP 4 mg Carbinoxamine Maleate Oral Solution, 4 mg/5 mLGenus Lifesciences Inc. | Mikart20240306
1edca669-8879-408a-b09c-259e363dd95cBreckenridge Pharmaceutical, Inc.20220923
748c233b-6ab9-42d0-89ab-e7ead30f7947Mikart, LLC20200521
1741b4f2-af49-43fe-8319-7b8a38fa25d2Carbinoxamine Maleate Tablets, USP 4 mg Carbinoxamine Maleate Oral Solution, 4 mg/5 mL Rx OnlyPar Pharmaceutical, Inc. | Sovereign Pharmaceuticals, LLC20180314
a195fb18-ff77-4d89-8593-7d5fdfeb16e4National Council for Prescription Drug Programs20130502
5beea552-df91-4786-879c-7f8432325e2eNational Council for Prescription Drug Programs20120724
71994333-a5ca-45ea-ab7f-3441296f609fNational Council for Prescription Drug Programs20120724
a7726228-add2-4733-b5d9-c0ef1c379e1eNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4carbinoxamine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epccarbinoxamine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moacarbinoxamine
MEDRTD011725PyridinesCHEMhas_ingredientcarbinoxamine maleate
MEDRTD011725PyridinesCHEMhas_ingredientcarbinoxamine
MEDRTD000799AngioedemaDISEASEmay_treatcarbinoxamine
MEDRTD000799AngioedemaDISEASEmay_treatcarbinoxamine maleate
MEDRTD001942Breast FeedingDISEASEci_withcarbinoxamine
MEDRTD001942Breast FeedingDISEASEci_withcarbinoxamine maleate
MEDRTD003233Conjunctivitis, AllergicDISEASEmay_treatcarbinoxamine
MEDRTD003233Conjunctivitis, AllergicDISEASEmay_treatcarbinoxamine maleate
MEDRTD003327Coronary DiseaseDISEASEci_withcarbinoxamine maleate
MEDRTD003327Coronary DiseaseDISEASEci_withcarbinoxamine
MEDRTD004342Drug HypersensitivityDISEASEci_withcarbinoxamine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withcarbinoxamine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withcarbinoxamine maleate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withcarbinoxamine
MEDRTD006973HypertensionDISEASEci_withcarbinoxamine maleate
MEDRTD006973HypertensionDISEASEci_withcarbinoxamine
MEDRTD007231Infant, NewbornDISEASEci_withcarbinoxamine maleate
MEDRTD007231Infant, NewbornDISEASEci_withcarbinoxamine
MEDRTD007234Infant, PrematureDISEASEci_withcarbinoxamine maleate
MEDRTD007234Infant, PrematureDISEASEci_withcarbinoxamine
MEDRTD007415Intestinal ObstructionDISEASEci_withcarbinoxamine
MEDRTD007415Intestinal ObstructionDISEASEci_withcarbinoxamine maleate
MEDRTD010437Peptic UlcerDISEASEci_withcarbinoxamine
MEDRTD010437Peptic UlcerDISEASEci_withcarbinoxamine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatcarbinoxamine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatcarbinoxamine maleate
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatcarbinoxamine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatcarbinoxamine maleate
MEDRTD013224Status AsthmaticusDISEASEci_withcarbinoxamine
MEDRTD013224Status AsthmaticusDISEASEci_withcarbinoxamine maleate
MEDRTD014517Ureteral ObstructionDISEASEci_withcarbinoxamine
MEDRTD014517Ureteral ObstructionDISEASEci_withcarbinoxamine maleate
MEDRTD014524Urethral ObstructionDISEASEci_withcarbinoxamine
MEDRTD014524Urethral ObstructionDISEASEci_withcarbinoxamine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moacarbinoxamine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moacarbinoxamine maleate
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moacarbinoxamine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moacarbinoxamine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pecarbinoxamine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pecarbinoxamine maleate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH4 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA040442
CODESANDAANDA090756
CODESSNOMEDCT1217335009
CODESVUID4004974
NAMESPrescribable Synonymcarbinoxamine maleate 4 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File