Cetirizine Hydrochloride NDC 61037-480

NDC codes

FDA NDC Directory

Product NDC (as listed)61037-480Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61037-0480Add 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
61037-480-02	61037048002	120 mL in 1 BOTTLE, PLASTIC (61037-480-02)Marketed from May 8, 2025
61037-480-03	61037048003	480 mL in 1 BOTTLE, PLASTIC (61037-480-03)Marketed from May 8, 2025
61037-480-04	61037048004	240 mL in 1 BOTTLE, PLASTIC (61037-480-04)Marketed from May 8, 2025
61037-480-06	61037048006	5 mL in 1 CUP, UNIT-DOSE (61037-480-06)Marketed from May 8, 2025
61037-480-12	61037048012	5 mL in 1 BOX, UNIT-DOSE (61037-480-12)Marketed from May 8, 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: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091327
Marketing start: May 8, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 61037-480_59fa0fa6-075c-826c-e063-6294a90a72fbSPL ID 59fa0fa6-075c-826c-e063-6294a90a72fbSPL set ID 36b24a3c-6284-5a6d-e063-6394a90a7743RxCUI 1014673UNII 64O047KTOAUPC 0361037480129, 0361037480020
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

N461037048002 followed by a unit qualifier and the quantity

Package 61037-0480-02. 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 26, 2026.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091327

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

FDA NDC Directory listings under ANDA 091327
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-357
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-358