CARBINOXAMINE MALEATE

Product NDC
69315-239
11-digit product format
693150239
Labeler code
69315
Product ID
69315-239_a6ac5a29-dc4e-425f-bcaf-d362b08e887c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARBINOXAMINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA215476
Marketing category
ANDA
Marketing start
2025-08-01
Substance
CARBINOXAMINE MALEATE
Active strength
6 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 MALEATE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02O55696WH
Rxcui1795581

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-239-01CARBINOXAMINE MALEATE100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-239-01EA - Each69315-239dd69c286-88ac-4235-942f-c968ecea821512025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795581carbinoxamine maleate 6 MG Oral TabletPSN02e13b55-2153-468e-a5bd-57dee062f47f3
1795581carbinoxamine maleate 6 MG Oral TabletSCD02e13b55-2153-468e-a5bd-57dee062f47f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69315-239-0169315023901100 TABLET in 1 BOTTLE (69315-239-01) 100 tablet2025-08-01NoNoHistorical