FDA.reportPublic FDA data

Carbinoxamine Maleate

Product NDC
51991-334
11-digit product format
519910334
Labeler code
51991
Product ID
51991-334_e95a03c6-f423-7177-e053-2a95a90a0add
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbinoxamine maleate
Dosage form
SYRUP
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA040458
Marketing category
ANDA
Marketing start
2012-12-10
Marketing end
2025-03-15
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-334-04ML - Milliliter51991-334018249a0-b3b6-4821-a532-c4fbca3d4f1e12013-04-01
51991-334-16ML - Milliliter51991-3340d52a3ae-f954-4a7c-8828-a11853d4b75012013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBINOXAMINE MALEATEACTIVE INGREDIENT02O55696WHCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
CARBINOXAMINEACTIVE MOIETY982A7M02H5CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-334CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE SYRUP [BRECKENRIDGE PHARMACEUTICAL, INC.]8Legacy NDC20220924_1edca669-8879-408a-b09c-259e363dd95c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-334-0451991033404118 mL in 1 BOTTLE, PLASTIC (51991-334-04) 118 ml2012-12-100000-00-00NoNoCurrent