Carbinoxamine Maleate

Product NDC
64950-243
11-digit product format
649500243
Labeler code
64950
Product ID
64950-243_12a85f25-d18a-4408-8c66-4e0182287026
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbinoxamine Maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
Genus Lifesciences Inc.
Application
ANDA040458
Marketing category
ANDA
Marketing start
2023-06-09
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
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02O55696WH
Rxcui1010696, 1012904

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
64950-243-04Carbinoxamine Maleate118 mL in 1 BOTTLE, PLASTICSOLUTION1186
64950-243-16Carbinoxamine Maleate473 mL in 1 BOTTLE, PLASTICSOLUTION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-243-04ML - Milliliter64950-2439af1b9b9-0ead-4f08-b03a-e49fe313cb3612023-07-06
64950-243-16ML - Milliliter64950-2439a866e94-d303-4a8f-ac77-3ce2263b088312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-243CARBINOXAMINE MALEATE SOLUTION CARBINOXAMINE MALEATE TABLET [GENUS LIFESCIENCES INC.]6Current NDC, 2 package rows20240315_9d11b197-cfdc-4b9b-9935-2920ccb6e522.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010696carbinoxamine maleate 4 MG in 5 mL Oral SolutionPSN9d11b197-cfdc-4b9b-9935-2920ccb6e5226
1012904carbinoxamine maleate 4 MG Oral TabletPSN9d11b197-cfdc-4b9b-9935-2920ccb6e5226
1010696carbinoxamine maleate 0.8 MG/ML Oral SolutionSCD9d11b197-cfdc-4b9b-9935-2920ccb6e5226
1012904carbinoxamine maleate 4 MG Oral TabletSCD9d11b197-cfdc-4b9b-9935-2920ccb6e5226
1010696carbinoxamine maleate 0.8 MG/ML Oral SyrupSY9d11b197-cfdc-4b9b-9935-2920ccb6e5226
1010696carbinoxamine maleate 4 MG per 5 ML Oral SolutionSY9d11b197-cfdc-4b9b-9935-2920ccb6e5226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-243-0464950024304118 mL in 1 BOTTLE, PLASTIC (64950-243-04) 118 ml2023-06-09NoNoHistorical
64950-243-1664950024316473 mL in 1 BOTTLE, PLASTIC (64950-243-16) 473 ml2023-06-09NoNoHistorical