NDC codes

FDA NDC Directory
Product NDC (as listed)81469-352Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81469-0352Add 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 NDC11-digit (billing)PackageCopy
81469-352-018146903520181469035201100 TABLET in 1 BOTTLE (81469-352-01)Marketed from Oct 2, 2026

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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
First Nation Group, LLCNDC labeler code 81469
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076047
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 81469-352_5c9ebb06-784f-4ef7-e063-6394a90aaf25SPL ID 5c9ebb06-784f-4ef7-e063-6394a90aaf25
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

N481469035201 followed by a unit qualifier and the quantity

Package 81469-0352-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 81469-352

What is NDC 81469-352?
81469-352 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 5 mg/1 tablet, listed with the FDA by First Nation Group, 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?
First Nation Group, LLC, NDC labeler code 81469. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralFirst Nation Group, LLC81469-35381469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-01748433-0017-20
Cetirizine hydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralAdvagen Pharma Ltd.,72888-48072888-0480-01
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-407268788-4072-0368788-4072-0668788-4072-09
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralBionpharma Inc.69452-42669452-0426-5569452-0426-88
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralRising Pharma Holdings, Inc.57237-35757237-0357-1257237-0357-24
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralRising Pharma Holdings, Inc.57237-35857237-0358-1257237-0358-24
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralBAJAJ MEDICAL, LLC61037-48061037-0480-0261037-0480-0361037-0480-04+2 more
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralBAJAJ MEDICAL, LLC61037-48061037-0480-2261037-0480-2361037-0480-24+2 more
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralAdvanced Rx LLC80513-73180513-0731-0580513-0731-12

All 108 Cetirizine Hydrochloride NDCs

Other NDCs under ANDA 076047

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

FDA NDC Directory listings under ANDA 076047
ProductStrengthForm · routeLabelerProduct NDC
Cetirizine HClcetirizineCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralGERI-CARE PHARMACEUTICAL CORP57896-992
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-458
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralFirst Nation Group, LLC81469-353
Cetirizine Hydrochloride 10 mgCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralContract Pharmacal Corp.10267-3579
Dr Simi Cetirizine Hydrochloride 10 mgcetirizine hydrochloride 10 mgCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralFarmacias De Similares TX LLC85786-203

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