What is NDC 83745-185?

83745-185 is the product NDC for Cetirizine Hydrochloride Oral Solution, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by APOZEAL PHARMACEUTICALS INC. It has 3 package NDCs, shown above in 10- and 11-digit form.

APOZEAL PHARMACEUTICALS INC, NDC labeler code 83745. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine Hydrochloride Oral Solution?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cetirizine Hydrochloride Oral Solution NDC 83745-185

NDC codes

FDA NDC Directory

Product NDC (as listed)83745-185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83745-0185Add 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
83745-185-04	83745018504	120 mL in 1 BOTTLE (83745-185-04)Marketed from Dec 20, 2024
83745-185-08	83745018508	240 mL in 1 BOTTLE (83745-185-08)Marketed from Dec 20, 2024
83745-185-16	83745018516	480 mL in 1 BOTTLE (83745-185-16)Marketed from Dec 20, 2024

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): Cetirizine Hydrochloride Oral Solution
Generic name (nonproprietary): cetirizine hydrochloride oral solution
Active ingredients: Cetirizine hydrochloride — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: APOZEAL PHARMACEUTICALS INCNDC labeler code 83745
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078870
Marketing start: Dec 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 83745-185_b350aaa9-197e-4ebc-8315-6ea307dcdb2eSPL ID b350aaa9-197e-4ebc-8315-6ea307dcdb2eSPL set ID 9c6a440b-bd0f-414b-bab3-3b2f57c479d7RxCUI 1014673UNII 64O047KTOAUPC 0383745185042, 0383745185165, 0383745185080
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

N483745018504 followed by a unit qualifier and the quantity

Package 83745-0185-04. 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 Jan 6, 2026.

Indications (excerpt from the label)

INDICATIONS & USAGE Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly red…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83745-185

What is NDC 83745-185?: 83745-185 is the product NDC for Cetirizine Hydrochloride Oral Solution, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by APOZEAL PHARMACEUTICALS INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine Hydrochloride Oral Solution.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: APOZEAL PHARMACEUTICALS INC, NDC labeler code 83745. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine Hydrochloride Oral Solution?: 2 other product NDCs are listed under this name. See all Cetirizine Hydrochloride Oral Solution 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 Cetirizine Hydrochloride Oral Solution NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine Hydrochloride Oral Solution	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-8890	68788-8890-01
Cetirizine Hydrochloride Oral Solution	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Chartwell RX, LLC	62135-057	62135-0057-4162135-0057-47

Other NDCs under ANDA 078870

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

FDA NDC Directory listings under ANDA 078870
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride Oral Solution	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Preferred Pharmaceuticals Inc.	68788-8890