Cetirizine Hydrochloride Oral Solution NDC 62135-057

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0057Add 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
62135-057-41	62135005741	120 mL in 1 BOTTLE (62135-057-41)Marketed from Jun 8, 2022
62135-057-47	62135005747	473 mL in 1 BOTTLE (62135-057-47)Marketed from Jun 8, 2022

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 — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078876
Marketing start: May 11, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 62135-057_06fce480-76eb-a204-e063-6394a90a3bbcSPL ID 06fce480-76eb-a204-e063-6394a90a3bbcSPL set ID 41dc7107-a2d2-4519-ac6f-cbed9f07e9bfRxCUI 1014673UNII 64O047KTOAUPC 0362135057411, 0362135057473
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

N462135005741 followed by a unit qualifier and the quantity

Package 62135-0057-41. 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 Oct 5, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Perennial Allergic Rhinitis: Cetirizine hydrochloride oral solution 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 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 reduces pru…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078876

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

FDA NDC Directory listings under ANDA 078876
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Aventura Pharmaceuticals, LLC	69206-990
Cetirizine hydrochloride	Cetirizine hydrochloride 5 mg/5mL	SolutionOral	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	23155-929