Cetirizine HCl (cetirizine) NDC 72657-131

NDC codes

FDA NDC Directory

Product NDC (as listed)72657-131Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72657-0131Add 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
72657-131-89	72657013189	1 KIT in 1 PACKAGE (72657-131-89) * 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLEMarketed from May 13, 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 HCl
Generic name (nonproprietary): cetirizine
Dosage form: Kit
Labeler: GLENMARK THERAPEUTICS INC., USA
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078427
Marketing start: May 13, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 72657-131_42c1f2da-97b4-4583-bf62-368be53900c2SPL ID 42c1f2da-97b4-4583-bf62-368be53900c2SPL set ID 04b08c52-5390-4cdb-a9e7-fca81fffdc73RxCUI 1014676, 1014678UNII 64O047KTOAUPC 0372657129350

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N472657013189 followed by a unit qualifier and the quantity

Package 72657-0131-89. 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 7, 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 078427

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

FDA NDC Directory listings under ANDA 078427
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine HClcetirizine	Cetirizine hydrochloride 10 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-1279
Cetirizine HClcetirizine	Cetirizine hydrochloride 5 mg/1	TabletOral	GLENMARK THERAPEUTICS INC., USA	72657-128
Cetirizine HClcetirizine	Cetirizine hydrochloride 10 mg/1	TabletOral	GLENMARK THERAPEUTICS INC., USA	72657-129
Cetirizine HClcetirizine	—	Kit	GLENMARK THERAPEUTICS INC., USA	72657-130