FDA.reportPublic FDA data

Karbinal

Product NDC
23594-101
11-digit product format
235940101
Labeler code
23594
Product ID
23594-101_4cd73883-efb6-9773-e063-6394a90a8285
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbinoxamine Maleate
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Aytu Therapeutics, LLC
Application
NDA022556
Marketing category
NDA
Marketing start
2014-01-03
Substance
CARBINOXAMINE MALEATE
Active strength
4 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Karbinal
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBINOXAMINE MALEATE4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02O55696WH
Rxcui1374770, 1374776

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78df9296-6f14-4da6-be68-48f965578efcProduct name220250814
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
0a10da58-f2d3-478e-b6c4-93af0553179dProduct name120160714
97ec1a04-ce45-92f5-7c19-1642e8f54f83Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23594-101-01KarbinalER30 mL in 1 BOTTLE, PLASTICSUSPENSION, EXTENDED RELEASE3015
23594-101-01KarbinalER2 in 1 CARTONSUSPENSION, EXTENDED RELEASE215
23594-101-05KarbinalER480 mL in 1 BOTTLE, PLASTICSUSPENSION, EXTENDED RELEASE48015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-101-05ML - Milliliter23594-10194c93b3b-10fa-46d8-8416-ba7d0f3029fe12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23594-101KARBINAL ER (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [AYTU THERAPEUTICS, LLC]14Current NDC, Legacy NDC, 3 package rows20250110_c40b3f4e-2d71-41a1-a1fc-f64f38724879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1374770carbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral SuspensionPSNc40b3f4e-2d71-41a1-a1fc-f64f3872487915
1374776Karbinal ER 4 MG in 5 mL 12HR Extended Release Oral SuspensionPSNc40b3f4e-2d71-41a1-a1fc-f64f3872487915
137477612 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal]SBDc40b3f4e-2d71-41a1-a1fc-f64f3872487915
137477012 HR carbinoxamine maleate 0.8 MG/ML Extended Release SuspensionSCDc40b3f4e-2d71-41a1-a1fc-f64f3872487915
137477612 HR Karbinal 0.8 MG/ML Extended Release SuspensionSYc40b3f4e-2d71-41a1-a1fc-f64f3872487915
1374770carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral SuspensionSYc40b3f4e-2d71-41a1-a1fc-f64f3872487915
1374776Karbinal 4 MG per 5 ML 12 HR Extended Release SuspensionSYc40b3f4e-2d71-41a1-a1fc-f64f3872487915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23594-101-01235940101012 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC2014-01-030000-00-00YesNoCurrent
23594-101-0523594010105480 mL in 1 BOTTLE, PLASTIC (23594-101-05) 480 ml2014-01-030000-00-00NoNoCurrent