FDA.reportPublic FDA data

Carbinoxamine Maleate

Product NDC
44523-825
11-digit product format
445230825
Labeler code
44523
Product ID
44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbinoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Biocomp Pharma, Inc.
Application
ANDA090756
Marketing category
ANDA
Marketing start
2011-05-27
Substance
CARBINOXAMINE MALEATE
Active strength
4 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbinoxamine Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBINOXAMINE MALEATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02O55696WH
Rxcui1012904

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78df9296-6f14-4da6-be68-48f965578efcProduct name220250814
0a10da58-f2d3-478e-b6c4-93af0553179dProduct name120160714
97ec1a04-ce45-92f5-7c19-1642e8f54f83Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44523-825-012024-03-06C16284748780-19d75b9d0-3865-f424-e053-dadaa90a57ceCarbinoxamine Maleate Tablets, USP 4 mg
44523-825-012024-01-30C16284748780-19d75b9d0-3865-f424-e053-dadaa90a57ceCarbinoxamine Maleate Tablets, USP 4 mg
44523-825-012020-08-11C16284748780-19d75b9d0-3865-f424-e053-dadaa90a57ceCarbinoxamine Maleate Tablets, USP 4 mg
44523-825-012020-01-31C16284748780-19d75b9d0-3865-f424-e053-dadaa90a57ceCarbinoxamine Maleate Tablets, USP 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-825-01Carbinoxamine Maleate100 in 1 BOTTLETABLET1008
44523-825-01Carbinoxamine Maleate1 in 1 CARTONTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-825-01EA - Each44523-8250d3ffa1d-e6cb-446e-9e1e-f29ec2a5587712015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBINOXAMINE MALEATEACTIVE INGREDIENT02O55696WHCARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]1
CARBINOXAMINEACTIVE MOIETY982A7M02H5CARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BCARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-825CARBINOXAMINE MALEATE TABLET [BIOCOMP PHARMA, INC.]7Current NDC, Legacy NDC, 2 package rows20240308_14266e97-674b-b6a9-37a2-a955f0a01c4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012904carbinoxamine maleate 4 MG Oral TabletPSN14266e97-674b-b6a9-37a2-a955f0a01c4f8
1012904carbinoxamine maleate 4 MG Oral TabletSCD14266e97-674b-b6a9-37a2-a955f0a01c4f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-825-01445230825011 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLE1 bottle2021-06-280000-00-00NoNoCurrent