karbinal er

Generic: carbinoxamine maleate

Labeler: aytu therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name karbinal er
Generic Name carbinoxamine maleate
Labeler aytu therapeutics, llc
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbinoxamine maleate 4 mg/5mL

Manufacturer
Aytu Therapeutics, LLC

Identifiers & Regulatory

Product NDC 23594-101
Product ID 23594-101_2b3620f5-171d-7afc-e063-6394a90a7aab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022556
Listing Expiration 2026-12-31
Marketing Start 2014-01-03

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23594101
Hyphenated Format 23594-101

Supplemental Identifiers

RxCUI
1374770 1374776
UNII
02O55696WH

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name karbinal er (source: ndc)
Generic Name carbinoxamine maleate (source: ndc)
Application Number NDA022556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC
  • 480 mL in 1 BOTTLE, PLASTIC (23594-101-05)
source: ndc

Packages (2)

23594-101-01 2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC 23594-101-05 480 mL in 1 BOTTLE, PLASTIC (23594-101-05)

Ingredients (1)

carbinoxamine maleate (4 mg/5mL)

Linked Drug Pages (1)

Karbinal ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b3620f5-171d-7afc-e063-6394a90a7aab", "openfda": {"unii": ["02O55696WH"], "rxcui": ["1374770", "1374776"], "spl_set_id": ["c40b3f4e-2d71-41a1-a1fc-f64f38724879"], "manufacturer_name": ["Aytu Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "23594-101-01", "marketing_start_date": "20140103"}, {"sample": false, "description": "480 mL in 1 BOTTLE, PLASTIC (23594-101-05)", "package_ndc": "23594-101-05", "marketing_start_date": "20140103"}], "brand_name": "Karbinal ER", "product_id": "23594-101_2b3620f5-171d-7afc-e063-6394a90a7aab", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "23594-101", "generic_name": "Carbinoxamine Maleate", "labeler_name": "Aytu Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Karbinal", "brand_name_suffix": "ER", "active_ingredients": [{"name": "CARBINOXAMINE MALEATE", "strength": "4 mg/5mL"}], "application_number": "NDA022556", "marketing_category": "NDA", "marketing_start_date": "20140103", "listing_expiration_date": "20261231"}