CARBZAH

Product NDC
71085-080
11-digit product format
710850080
Labeler code
71085
Product ID
71085-080_37b3e7c3-81ea-3a36-e063-6294a90a3d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbinoxamine Maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
IPG Pharmaceuticals, inc.
Application
ANDA040458
Marketing category
ANDA
Marketing start
2025-06-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARBZAH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBINOXAMINE MALEATE4 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02O55696WH
Rxcui1010696, 2730039

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
71085-080-07CARBZAH473 mL in 1 BOTTLE, PLASTICSOLUTION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-080-07ML - Milliliter71085-080aa4c356f-605d-4aa9-9fc8-de540bc934bb12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010696carbinoxamine maleate 4 MG in 5 mL Oral SolutionPSNa845fc15-c675-4e33-840c-6a74e79d0ced3
2730039CARBZAH 4 MG in 5 mL Oral SolutionPSNa845fc15-c675-4e33-840c-6a74e79d0ced3
2730039carbinoxamine maleate 0.8 MG/ML Oral Solution [Carbzah]SBDa845fc15-c675-4e33-840c-6a74e79d0ced3
1010696carbinoxamine maleate 0.8 MG/ML Oral SolutionSCDa845fc15-c675-4e33-840c-6a74e79d0ced3
1010696carbinoxamine maleate 0.8 MG/ML Oral SyrupSYa845fc15-c675-4e33-840c-6a74e79d0ced3
1010696carbinoxamine maleate 4 MG per 5 ML Oral SolutionSYa845fc15-c675-4e33-840c-6a74e79d0ced3
2730039Carbzah 4 MG per 5 ML Oral SolutionSYa845fc15-c675-4e33-840c-6a74e79d0ced3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71085-080-0771085008007473 mL in 1 BOTTLE, PLASTIC (71085-080-07) 473 ml2025-06-01NoNoCurrent