What is NDC 23594-101?

23594-101 is the product NDC for Karbinal ER (carbinoxamine maleate), Carbinoxamine maleate 4 mg/5mL suspension, extended release, listed with the FDA by Aytu Therapeutics, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Karbinal ER (Carbinoxamine Maleate).

Aytu Therapeutics, LLC, NDC labeler code 23594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Karbinal ER?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Karbinal ER NDC 23594-101 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)23594-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width23594-0101Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
23594-101-01	2359401010123594010101	2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTICMarketed from Jan 3, 2014 · Sample package
23594-101-05	2359401010523594010105	480 mL in 1 BOTTLE, PLASTIC (23594-101-05)Marketed from Jan 3, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Karbinal ERSuffix: ER
Generic name (nonproprietary): carbinoxamine maleate
Active ingredients: Carbinoxamine maleate — 4 mg/5mL
Dosage form: Suspension, Extended release
Route: Oral
Labeler: Aytu Therapeutics, LLCNDC labeler code 23594
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022556
Marketing start: Jan 3, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 23594-101_4cd73883-efb6-9773-e063-6394a90a8285SPL ID 4cd73883-efb6-9773-e063-6394a90a8285SPL set ID c40b3f4e-2d71-41a1-a1fc-f64f38724879RxCUI 1374770, 1374776UNII 02O55696WHUPC 0323594101053
Pharmacologic class: Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N423594010101 followed by a unit qualifier and the quantity

Package 23594-0101-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 12, 2026.

Indications (excerpt from the label)

Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled Amelioration of the severity of allergic reactions to blood or plasma Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhini…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 23594-101

What is NDC 23594-101?: 23594-101 is the product NDC for Karbinal ER (carbinoxamine maleate), Carbinoxamine maleate 4 mg/5mL suspension, extended release, listed with the FDA by Aytu Therapeutics, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Karbinal ER (Carbinoxamine Maleate).
What is the active ingredient?: Carbinoxamine maleate.
Who is the labeler?: Aytu Therapeutics, LLC, NDC labeler code 23594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Karbinal ER?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 022556

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022556
Product	Strength	Form · route	Labeler	Product NDC
Carbinoxamine Maleate Extended-Release Oral Suspensioncarbinoxamine maleate	Carbinoxamine maleate 4 mg/5mL	Suspension, Extended releaseOral	Neos Therapeutics, LP	62542-101

Karbinal ER (Carbinoxamine maleate) NDC 23594-101