What is NDC 55319-939?

55319-939 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by FAMILY DOLLAR SERVICES, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.

FAMILY DOLLAR SERVICES, INC, NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine Hydrochloride?

107 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	5531909393055319093930	30 TABLET in 1 BOTTLE (55319-939-30)Marketed from Sep 1, 2017
55319-939-54	5531909395455319093954	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, INCNDC labeler code 55319
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)

About NDC 55319-939

What is NDC 55319-939?: 55319-939 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by FAMILY DOLLAR SERVICES, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine Hydrochloride.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: FAMILY DOLLAR SERVICES, INC, NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine Hydrochloride?: 107 other product NDCs are listed under this name. See all Cetirizine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cetirizine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	First Nation Group, LLC	81469-352	81469-0352-01
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	First Nation Group, LLC	81469-353	81469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-017	48433-0017-20
Cetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Advagen Pharma Ltd.,	72888-480	72888-0480-01
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4072	68788-4072-0368788-4072-0668788-4072-09
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Bionpharma Inc.	69452-426	69452-0426-5569452-0426-88
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-357	57237-0357-1257237-0357-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-358	57237-0358-1257237-0358-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-2261037-0480-2361037-0480-24+2 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-0261037-0480-0361037-0480-04+2 more

All 108 Cetirizine Hydrochloride NDCs

Other NDCs under ANDA 077498

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

FDA NDC Directory listings under ANDA 077498
Product	Strength	Form · route	Labeler	Product NDC
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	LIDL US, LLC	71141-133
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Valu Merchandisers Company	63941-939
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Sportpharm LLC	85766-205
Quality Choice Cetirizine Hydrochloridecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Chain Drug Marketing Association Inc.	63868-132
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Ohm Laboratories Inc.	51660-939
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Chain Drug Consortium, LLC	68016-939
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-821
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Marlex Pharmaceuticals, Inc	10135-762
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Marc Glassman, Inc.	68998-939
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2571
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	55289-995
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Proficient Rx LP	63187-110
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Publix Super Markets Inc	56062-939