NDC codes

FDA NDC Directory
Product NDC (as listed)44523-825Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44523-0825Add 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 NDC11-digit (billing)PackageCopy
44523-825-0144523082501445230825011 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLEMarketed from Jun 28, 2021

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)
Carbinoxamine Maleate
Generic name (nonproprietary)
carbinoxamine maleate
Active ingredients
Carbinoxamine maleate — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Biocomp Pharma, Inc.NDC labeler code 44523
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090756
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7SPL ID 462c3a74-f82a-4fda-e063-6294a90ab0a7SPL set ID 14266e97-674b-b6a9-37a2-a955f0a01c4fRxCUI 1012904UNII 02O55696WH
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

N444523082501 followed by a unit qualifier and the quantity

Package 44523-0825-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Carbinoxamine maleate is effective 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 angio-edema. 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 44523-825

What is NDC 44523-825?
44523-825 is the product NDC for Carbinoxamine Maleate, Carbinoxamine maleate 4 mg/1 tablet, listed with the FDA by Biocomp Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carbinoxamine Maleate.
What is the active ingredient?
Carbinoxamine maleate.
Who is the labeler?
Biocomp Pharma, Inc., NDC labeler code 44523. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carbinoxamine Maleate?
5 other product NDCs are listed under this name. See all Carbinoxamine Maleate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Carbinoxamine Maleate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Carbinoxamine MaleateCarbinoxamine maleate 6 mg/1TabletOralLeading Pharma, LLC69315-23969315-0239-01
Carbinoxamine MaleateCarbinoxamine maleate 6 mg/1TabletOralTRIPOINT THERAPEUTICS, LLC80705-12080705-0120-30
Carbinoxamine MaleateCarbinoxamine maleate 6 mg/1TabletOralBluCrest Pharmaceuticals, LLC73684-11073684-0110-60
Carbinoxamine MaleateCarbinoxamine maleate 4 mg/1TabletOralGenus Lifesciences Inc.64950-21164950-0211-01
Carbinoxamine MaleateCarbinoxamine maleate 4 mg/5mLSolutionOralGenus Lifesciences Inc.64950-24364950-0243-0464950-0243-16

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