Cetirizine Hydrochloride NDC 55319-939

NDC codes

FDA NDC Directory

Product NDC (as listed)55319-939Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55319-0939Add 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
55319-939-30	55319093930	30 TABLET in 1 BOTTLE (55319-939-30)Marketed from Sep 1, 2017
55319-939-54	55319093954	14 TABLET in 1 BLISTER PACK (55319-939-54)Marketed from Sep 1, 2017

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: FAMILY DOLLAR SERVICES, INC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077498
Marketing start: Sep 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 55319-939_65ed577d-07a6-40e5-bff5-26b9ec806f04SPL ID 65ed577d-07a6-40e5-bff5-26b9ec806f04SPL set ID b326dacc-6123-47a7-9fde-6909db1d780bRxCUI 1014678UNII 64O047KTOA
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

N455319093930 followed by a unit qualifier and the quantity

Package 55319-0939-30. 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 Jan 8, 2018.

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)