Cetirizine Hydrochloride NDC 61037-479

NDC codes

FDA NDC Directory

Product NDC (as listed)61037-479Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61037-0479Add 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
61037-479-04	61037047904	240 mL in 1 BOTTLE, PLASTIC (61037-479-04)Marketed from Jun 6, 2025

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
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: BAJAJ MEDICAL, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090191
Marketing start: Sep 12, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 61037-479_3b5908fd-b2c0-ba45-e063-6294a90a6fb0SPL ID 3b5908fd-b2c0-ba45-e063-6294a90a6fb0SPL set ID 3b5908f1-faba-c317-e063-6294a90aa8a7RxCUI 1014673UNII 64O047KTOAUPC 0361037479048
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

N461037047904 followed by a unit qualifier and the quantity

Package 61037-0479-04. 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 Aug 1, 2025.

Indications (excerpt from the label)

INDICATIONS AND 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)

Other NDCs under ANDA 090191

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

FDA NDC Directory listings under ANDA 090191
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	16571-134