Cetirizine Hydrochloride Tablets, 5 mg NDC 25000-219

NDC codes

FDA NDC Directory

Product NDC (as listed)25000-219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25000-0219Add 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
25000-219-03	25000021903	1 BOTTLE in 1 CARTON (25000-219-03) / 30 TABLET in 1 BOTTLEMarketed from Jan 13, 2022
25000-219-08	25000021908	1 BOTTLE in 1 CARTON (25000-219-08) / 100 TABLET in 1 BOTTLEMarketed from Jan 13, 2022
25000-219-14	25000021914	1000 TABLET in 1 BOTTLE (25000-219-14)Marketed from Jan 13, 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 Tablets, 5 mg
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: MARKSANS PHARMA LIMITED
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078933
Marketing start: Jan 13, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 25000-219_172d56b9-ba90-4e1b-934a-f75307564ea3SPL ID 172d56b9-ba90-4e1b-934a-f75307564ea3SPL set ID 652b0c65-a3f2-4454-9cf2-51a3389282ccRxCUI 1014676, 1014678UNII 64O047KTOAUPC 0325000160814, 0325000219147, 0325000219086, 0325000160036, 0325000160142, 0325000220785, 0325000220037, 0325000220082, 0325000219031, 0325000220143, 0325000220815
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

N425000021903 followed by a unit qualifier and the quantity

Package 25000-0219-03. 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 Jul 10, 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 078933

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

FDA NDC Directory listings under ANDA 078933
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	BETTER LIVING BRANDS, LLC	21130-712
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	WALGREENS	0363-1794
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-160
Cetirizine Hydrochloride Tablets, 10 mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-220
Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-842
All Day Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	DOLGENCORP, INC.	55910-269
Allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Kroger Company	41226-692
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	TIME CAP LABORATORIES, INC.	49483-682
Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	TIME CAP LABORATORIES, INC.	49483-692