What is NDC 85293-001?

85293-001 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Umasuto, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Umasuto, LLC, NDC labeler code 85293. 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 85293-001

NDC codes

FDA NDC Directory

Product NDC (as listed)85293-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85293-0001Add 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
85293-001-01	8529300010185293000101	100 TABLET in 1 BOTTLE (85293-001-01)Marketed from Mar 4, 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Umasuto, LLCNDC labeler code 85293
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077829
Marketing start: Mar 4, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 85293-001_2fb2f0c8-a45a-5c2a-e063-6394a90a1587SPL ID 2fb2f0c8-a45a-5c2a-e063-6394a90a1587SPL set ID 9af4ab23-d6d3-43f9-a026-76fd9771963fRxCUI 1014678UNII 64O047KTOAUPC 0385293001010
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

N485293000101 followed by a unit qualifier and the quantity

Package 85293-0001-01. 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 Mar 6, 2025.

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 85293-001

What is NDC 85293-001?: 85293-001 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Umasuto, LLC. It has 1 package NDC, 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?: Umasuto, LLC, NDC labeler code 85293. 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 077829

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

FDA NDC Directory listings under ANDA 077829
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Prodose, Inc	68210-4159
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services LLC	70677-1241
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	Pioneer Life Sciences, LLC	72090-028
Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 10 mg/1	TabletOral	NUVICARE LLC	84324-001
Cabinet All Day Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Cabinet Health P.B.C.	82725-3103
Cabinet Allergy Relief Refill Cetirizine HCIcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Cabinet Health P.B.C.	82725-3003
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-401
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-402
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-886
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-4914
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-1964
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	Proficient Rx LP	71205-093
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Proficient Rx LP	71205-164
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-0300
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Sportpharm LLC	85766-149
CVS Cetirizine Hydrochloridecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	CVS Pharmacy	51316-182
GOOD REMEDIES All Day Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Strive Pharmaceuticals Inc.	70692-801
Goodmeds All Day Allergy Relief Cetirizine HClcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Cabinet Health P.B.C.	82725-4103
Indoor and Outdoor Allergy Reliefcetirizine hcl	Cetirizine hydrochloride 25 mg/1	Tablet, CoatedOral	Famora Inc.	87509-0002
RIGHT REMEDIES ALL-DAY Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Strive Pharmaceuticals Inc.	70692-180

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