FDA.reportPublic FDA data

12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension

RxCUI
1374770
RxNorm name
12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension
Display name
Carbinoxamine XR (Oral Liquid)
Full name
12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension
Term type
SCD
Status
Active
Strength
4 mg/5ml
Dose form
12 HR XR Susp
Route
Oral Liquid
Updated
2026-07-27 06:57:45

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052013
Active start
052013
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
carbinoxamine maleate0.8 MG / 1 MLcarbinoxaminecarbinoxamine maleate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Suspension316946

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
carbinoxamine20220

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STR12 HR carbinoxamine maleate 0.8 MG/ML Extended Release SuspensionNAMES
RxNorm Name12 HR carbinoxamine maleate 0.8 MG/ML Extended Release SuspensionNAMES
RxNorm Synonymcarbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral SuspensionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID199f46e5-6288-5627-e063-6294a90ae086CODES
RxCUI1374770CODES
MMSL_CODEBD29521CODES
MMSL_CODECD29521CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
62542-101-0562542-101Carbinoxamine Maleate Extended-Release Oral Suspension Carbinoxamine MaleateNeos Therapeutics, LPNDA022556

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02255662542-101Carbinoxamine Maleate Extended-Release Oral Suspension Carbinoxamine MaleateNDA AUTHORIZED GENERICNeos Therapeutics, LP

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
62542010105rxnav_ndcsyes

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c40b3f4e-2d71-41a1-a1fc-f64f38724879carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral SuspensionSY15These highlights do not include all the information needed to use KARBINAL ® ER safely and effectively. See full prescribing information for KARBINAL ® ER. Karbinal ® ER (carbinoxamine maleate) extended-release oral suspension Initial U.S. Approval: 195320260312
c40b3f4e-2d71-41a1-a1fc-f64f38724879carbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral SuspensionPSN15These highlights do not include all the information needed to use KARBINAL ® ER safely and effectively. See full prescribing information for KARBINAL ® ER. Karbinal ® ER (carbinoxamine maleate) extended-release oral suspension Initial U.S. Approval: 195320260312
c40b3f4e-2d71-41a1-a1fc-f64f3872487912 HR carbinoxamine maleate 0.8 MG/ML Extended Release SuspensionSCD15These highlights do not include all the information needed to use KARBINAL ® ER safely and effectively. See full prescribing information for KARBINAL ® ER. Karbinal ® ER (carbinoxamine maleate) extended-release oral suspension Initial U.S. Approval: 195320260312
199f46e5-6288-5627-e063-6294a90ae086carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral SuspensionSY4These highlights do not include all the information needed to use Carbinoxamine Maleate Extended-Release Oral Suspension. See full prescribing information for Carbinoxamine Maleate Extended-Release Oral Suspension. Initial U.S. Approval: 195320260312
199f46e5-6288-5627-e063-6294a90ae086carbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral SuspensionPSN4These highlights do not include all the information needed to use Carbinoxamine Maleate Extended-Release Oral Suspension. See full prescribing information for Carbinoxamine Maleate Extended-Release Oral Suspension. Initial U.S. Approval: 195320260312
199f46e5-6288-5627-e063-6294a90ae08612 HR carbinoxamine maleate 0.8 MG/ML Extended Release SuspensionSCD4These highlights do not include all the information needed to use Carbinoxamine Maleate Extended-Release Oral Suspension. See full prescribing information for Carbinoxamine Maleate Extended-Release Oral Suspension. Initial U.S. Approval: 195320260312

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
199f46e5-6288-5627-e063-6294a90ae086These highlights do not include all the information needed to use Carbinoxamine Maleate Extended-Release Oral Suspension. See full prescribing information for Carbinoxamine Maleate Extended-Release Oral Suspension. Initial U.S. Approval: 1953Neos Therapeutics, LP | Tris Pharma, Inc20260312

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_STRENGTH0.8 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESQUANTITY12 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD29521
CODESMMSL_CODECD29521
CODESRxCUI1374770
CODESSPL_SET_ID199f46e5-6288-5627-e063-6294a90ae086
CODESVUID4033365
NAMESPrescribable Synonymcarbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral Suspension
NAMESRXNAV_STR12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension
NAMESRxNorm Name12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension
NAMESRxNorm Synonymcarbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral Suspension
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File