What is NDC 64950-243?

64950-243 is the product NDC for Carbinoxamine Maleate, Carbinoxamine maleate 4 mg/5mL solution, listed with the FDA by Genus Lifesciences Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Genus Lifesciences Inc., NDC labeler code 64950. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carbinoxamine Maleate NDC 64950-243

NDC codes

FDA NDC Directory

Product NDC (as listed)64950-243Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64950-0243Add 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
64950-243-04	6495002430464950024304	118 mL in 1 BOTTLE, PLASTIC (64950-243-04)Marketed from Jun 9, 2023
64950-243-16	6495002431664950024316	473 mL in 1 BOTTLE, PLASTIC (64950-243-16)Marketed from Jun 9, 2023

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/5mL
Dosage form: Solution
Route: Oral
Labeler: Genus Lifesciences Inc.NDC labeler code 64950
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040458
Marketing start: Jun 9, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 64950-243_12a85f25-d18a-4408-8c66-4e0182287026SPL ID 12a85f25-d18a-4408-8c66-4e0182287026SPL set ID 9d11b197-cfdc-4b9b-9935-2920ccb6e522RxCUI 1010696, 1012904UNII 02O55696WHUPC 0364950211016
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

N464950024304 followed by a unit qualifier and the quantity

Package 64950-0243-04. 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 6, 2024.

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 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64950-243

What is NDC 64950-243?: 64950-243 is the product NDC for Carbinoxamine Maleate, Carbinoxamine maleate 4 mg/5mL solution, listed with the FDA by Genus Lifesciences Inc.. It has 2 package NDCs, 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?: Genus Lifesciences Inc., NDC labeler code 64950. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Carbinoxamine Maleate	Carbinoxamine maleate 6 mg/1	TabletOral	Leading Pharma, LLC	69315-239	69315-0239-01
Carbinoxamine Maleate	Carbinoxamine maleate 6 mg/1	TabletOral	TRIPOINT THERAPEUTICS, LLC	80705-120	80705-0120-30
Carbinoxamine Maleate	Carbinoxamine maleate 6 mg/1	TabletOral	BluCrest Pharmaceuticals, LLC	73684-110	73684-0110-60
Carbinoxamine Maleate	Carbinoxamine maleate 4 mg/1	TabletOral	Genus Lifesciences Inc.	64950-211	64950-0211-01
Carbinoxamine Maleate	Carbinoxamine maleate 4 mg/1	TabletOral	Biocomp Pharma, Inc.	44523-825	44523-0825-01

Other NDCs under ANDA 040458

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

FDA NDC Directory listings under ANDA 040458
Product	Strength	Form · route	Labeler	Product NDC
Carbzahcarbinoxamine maleate	Carbinoxamine maleate 4 mg/5mL	SolutionOral	IPG Pharmaceuticals, inc.	71085-080