NDC 23594-101

Karbinal ER

Carbinoxamine Maleate

Karbinal ER is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Zylera Pharmaceuticals, L. The primary component is Carbinoxamine M.

• Product ID: 23594-101_560b2020-c8ab-48da-8c02-9f07c2ce12db
• NDC: 23594-101
• Product Type: Human Prescription Drug
• Proprietary Name: Karbinal ER
• Generic Name: Carbinoxamine Maleate
• Dosage Form: Suspension, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-03
• Marketing Category: NDA / NDA
• Application Number: NDA022556
• Labeler Name: Zylera Pharmaceuticals, L
• Substance Name: CARBINOXAMINE M
• Active Ingredient Strength: 4 mg/5mL
• Pharm Classes: Histamine-1 Rec
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 23594-101-01

2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) > 30 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2014-01-03
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 23594-101-01 [23594010101]

Karbinal ER SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022556
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-03

NDC 23594-101-05 [23594010105]

Karbinal ER SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022556
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-03

Drug Details

Active Ingredients

Ingredient	Strength
CARBINOXAMINE MALEATE	4 mg/5mL

Pharmacological Class

• Histamine-1 Receptor Antagonist [EPC]
• Histamine H1 Receptor Antagonists [MoA]

Medicade Reported Pricing

23594010105 KARBINAL ER 4 MG/5 ML SUSP

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Karbinal ER" or generic name "Carbinoxamine Maleate"

NDC	Brand Name	Generic Name
44523-825	Carbinoxamine Maleate	Carbinoxamine Maleate
46672-191	carbinoxamine maleate	carbinoxamine maleate
46672-644	carbinoxamine maleate	carbinoxamine maleate
46672-857	carbinoxamine maleate	carbinoxamine maleate
51991-333	Carbinoxamine Maleate	carbinoxamine maleate
51991-334	Carbinoxamine Maleate	carbinoxamine maleate
64376-605	Carbinoxamine Maleate	Carbinoxamine Maleate
64376-612	Carbinoxamine Maleate	Carbinoxamine Maleate
69067-240	Carbinoxamine Maleate	CARBINOXAMINE MALEATE
23594-101	Karbinal	Carbinoxamine Maleate
15370-130	RyVent	carbinoxamine maleate