Home RxNorm 1374776 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1374776
RxNorm name 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal]
Display name KARBINAL XR (Oral Liquid)
Full name 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal]
Term type SBD
Status Active
Strength 4 mg/5ml
Dose form 12 HR XR Susp
Route Oral Liquid
Updated 2026-07-27 06:57:53 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 052013
Active start 052013
Multiple ingredient NO
Branded YES Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength carbinoxamine maleate 0.8 MG / 1 ML carbinoxamine carbinoxamine maleate
Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 23594-101-01 23594-101 Karbinal Carbinoxamine Maleate Aytu Therapeutics, LLC NDA022556 23594-101-05 23594-101 Karbinal Carbinoxamine Maleate Aytu Therapeutics, LLC NDA022556
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA022556 23594-101 Karbinal Carbinoxamine Maleate NDA Aytu Therapeutics, LLC
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.
NDC11, Source, Active table NDC11 Source Active 23594010101 rxnav_ndcs yes 23594010105 rxnav_ndcs yes 13551010101 rxnav_historical 13551010105 rxnav_historical 27808004603 rxnav_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 · 1 matching rows.
DailyMed RxNorm Mappings# Set ID, RxNorm string, TTY table Set ID RxNorm string TTY SPL version Label Effective c40b3f4e-2d71-41a1-a1fc-f64f38724879 Karbinal 4 MG per 5 ML 12 HR Extended Release Suspension SY 15 These 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: 1953 20260312 c40b3f4e-2d71-41a1-a1fc-f64f38724879 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal] SBD 15 These 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: 1953 20260312 c40b3f4e-2d71-41a1-a1fc-f64f38724879 Karbinal ER 4 MG in 5 mL 12HR Extended Release Oral Suspension PSN 15 These 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: 1953 20260312 c40b3f4e-2d71-41a1-a1fc-f64f38724879 12 HR Karbinal 0.8 MG/ML Extended Release Suspension SY 15 These 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: 1953 20260312
DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective c40b3f4e-2d71-41a1-a1fc-f64f38724879 These 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: 1953 Aytu Therapeutics, LLC 20260312
Drug Classes# Source, Class ID, Class table Source Class ID Class Type Relationship Drug concept ATC R06AA Aminoalkyl ethers ATC1-4 carbinoxamine FDASPL N0000175587 Histamine-1 Receptor Antagonist EPC has_epc carbinoxamine FDASPL N0000000190 Histamine H1 Receptor Antagonists MOA has_moa carbinoxamine MEDRT D011725 Pyridines CHEM has_ingredient carbinoxamine maleate MEDRT D011725 Pyridines CHEM has_ingredient carbinoxamine MEDRT D000799 Angioedema DISEASE may_treat carbinoxamine MEDRT D000799 Angioedema DISEASE may_treat carbinoxamine maleate MEDRT D001942 Breast Feeding DISEASE ci_with carbinoxamine MEDRT D001942 Breast Feeding DISEASE ci_with carbinoxamine maleate MEDRT D003233 Conjunctivitis, Allergic DISEASE may_treat carbinoxamine MEDRT D003233 Conjunctivitis, Allergic DISEASE may_treat carbinoxamine maleate MEDRT D003327 Coronary Disease DISEASE ci_with carbinoxamine maleate MEDRT D003327 Coronary Disease DISEASE ci_with carbinoxamine MEDRT D004342 Drug Hypersensitivity DISEASE ci_with carbinoxamine maleate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with carbinoxamine MEDRT D015812 Glaucoma, Angle-Closure DISEASE ci_with carbinoxamine maleate MEDRT D015812 Glaucoma, Angle-Closure DISEASE ci_with carbinoxamine MEDRT D006973 Hypertension DISEASE ci_with carbinoxamine maleate MEDRT D006973 Hypertension DISEASE ci_with carbinoxamine MEDRT D007231 Infant, Newborn DISEASE ci_with carbinoxamine maleate MEDRT D007231 Infant, Newborn DISEASE ci_with carbinoxamine MEDRT D007234 Infant, Premature DISEASE ci_with carbinoxamine maleate MEDRT D007234 Infant, Premature DISEASE ci_with carbinoxamine MEDRT D007415 Intestinal Obstruction DISEASE ci_with carbinoxamine MEDRT D007415 Intestinal Obstruction DISEASE ci_with carbinoxamine maleate MEDRT D010437 Peptic Ulcer DISEASE ci_with carbinoxamine MEDRT D010437 Peptic Ulcer DISEASE ci_with carbinoxamine maleate MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat carbinoxamine MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat carbinoxamine maleate MEDRT D012223 Rhinitis, Vasomotor DISEASE may_treat carbinoxamine MEDRT D012223 Rhinitis, Vasomotor DISEASE may_treat carbinoxamine maleate MEDRT D013224 Status Asthmaticus DISEASE ci_with carbinoxamine MEDRT D013224 Status Asthmaticus DISEASE ci_with carbinoxamine maleate MEDRT D014517 Ureteral Obstruction DISEASE ci_with carbinoxamine MEDRT D014517 Ureteral Obstruction DISEASE ci_with carbinoxamine maleate MEDRT D014524 Urethral Obstruction DISEASE ci_with carbinoxamine MEDRT D014524 Urethral Obstruction DISEASE ci_with carbinoxamine maleate MEDRT N0000000190 Histamine H1 Receptor Antagonists MOA has_moa carbinoxamine MEDRT N0000000190 Histamine H1 Receptor Antagonists MOA has_moa carbinoxamine maleate MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa carbinoxamine MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa carbinoxamine maleate MEDRT N0000008657 Decreased Histamine Activity PE has_pe carbinoxamine MEDRT N0000008657 Decreased Histamine Activity PE has_pe carbinoxamine maleate
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 0.8 MG/ML ATTRIBUTES GENERAL_CARDINALITY SINGLE ATTRIBUTES HUMAN_DRUG US ATTRIBUTES PRESCRIBABLE Y ATTRIBUTES QUANTITY 12 HR ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 ATTRIBUTES TTY SBD CODES MMSL_CODE BD29521 CODES NDA NDA022556 CODES RxCUI 1374776 CODES SPL_SET_ID c40b3f4e-2d71-41a1-a1fc-f64f38724879 NAMES Prescribable Synonym Karbinal ER 4 MG in 5 mL 12HR Extended Release Oral Suspension NAMES RXNAV_STR 12 HR Karbinal 0.8 MG/ML Extended Release Suspension NAMES RxNorm Name 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal] NAMES RxNorm Synonym 12 HR Karbinal 0.8 MG/ML Extended Release Suspension NAMES RxNorm Synonym Karbinal 4 MG per 5 ML 12 HR Extended Release Suspension SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon