Carbinoxamine Maleate

Product NDC
80705-120
11-digit product format
807050120
Labeler code
80705
Product ID
80705-120_28237aea-8a3c-40ca-b2a1-0b7248ce5b99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbinoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
TRIPOINT THERAPEUTICS, LLC
Application
ANDA215476
Marketing category
ANDA
Marketing start
2025-07-22
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
80705-120-30Carbinoxamine Maleate30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80705-120-30EA - Each80705-1206153662e-a60e-4473-a6da-0f258ece546212025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795581carbinoxamine maleate 6 MG Oral TabletPSN91ee2e99-082a-4157-b71b-1a7c0e5464fa2
1795581carbinoxamine maleate 6 MG Oral TabletSCD91ee2e99-082a-4157-b71b-1a7c0e5464fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80705-120-308070501203030 TABLET in 1 BOTTLE (80705-120-30) 30 tablet2025-07-22NoNoHistorical