FDA.reportPublic FDA data

Carbinoxamine Maleate Extended-Release Oral Suspension

Product NDC
62542-101
11-digit product format
625420101
Labeler code
62542
Product ID
62542-101_4cdb19d3-49f4-c257-e063-6294a90aaabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbinoxamine Maleate
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Neos Therapeutics, LP
Application
NDA022556
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-06-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbinoxamine Maleate Extended-Release Oral Suspension
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBINOXAMINE MALEATE4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02O55696WH
Rxcui1374770

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78df9296-6f14-4da6-be68-48f965578efcProduct name220250814
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0a10da58-f2d3-478e-b6c4-93af0553179dProduct name120160714
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
97ec1a04-ce45-92f5-7c19-1642e8f54f83Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62542-101-05Carbinoxamine Maleate Extended-Release Oral Suspension480 mL in 1 BOTTLE, PLASTICSUSPENSION, EXTENDED RELEASE4804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62542-101-05ML - Milliliter62542-10118b55b97-b4cf-476a-a2cd-b74516a57cbe12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62542-101CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE) SUSPENSION, EXTENDED RELEASE [NEOS THERAPEUTICS LP]1Current NDC, 1 package rows20240606_199f46e5-6288-5627-e063-6294a90ae086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1374770carbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral SuspensionPSN199f46e5-6288-5627-e063-6294a90ae0864
137477012 HR carbinoxamine maleate 0.8 MG/ML Extended Release SuspensionSCD199f46e5-6288-5627-e063-6294a90ae0864
1374770carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral SuspensionSY199f46e5-6288-5627-e063-6294a90ae0864

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62542-101-0562542010105480 mL in 1 BOTTLE, PLASTIC (62542-101-05) 480 ml2024-06-01NoNoHistorical