Over-the-counter drug · ANDA

Allergy Relief (Cetirizine hydrochloride) NDC 57344-194

Cetirizine hydrochloride 10 mg/1 · Tablet, Coated · Oral · AAA PHARMACEUTICAL, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)57344-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57344-0194Add 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
57344-194-0157344019401573440194011 BOTTLE, PLASTIC in 1 CARTON (57344-194-01) / 14 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 1, 2018
57344-194-1457344019414573440194141 BOTTLE, PLASTIC in 1 CARTON (57344-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Apr 29, 2022
57344-194-20573440194205734401942045 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-194-20)Marketed from May 28, 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)
Allergy Relief
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
AAA PHARMACEUTICAL, INC.NDC labeler code 57344
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 57344-194_52e3fa47-d8fe-183e-e063-6294a90a5a75SPL ID 52e3fa47-d8fe-183e-e063-6294a90a5a75SPL set ID ac22558b-5c82-4ab9-95b8-53eedea46282RxCUI 1014678UNII 64O047KTOAUPC 0099581911768
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

N457344019401 followed by a unit qualifier and the quantity

Package 57344-0194-01. 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 .

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 57344-194

What is NDC 57344-194?
57344-194 is the product NDC for Allergy Relief (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by AAA PHARMACEUTICAL, INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Allergy Relief (Cetirizine hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
AAA PHARMACEUTICAL, INC., NDC labeler code 57344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allergy Relief?
271 other product NDCs are listed under this name. See all Allergy Relief 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 Allergy Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralFamora Inc.87509-000387509-0003-06
Allergy Relieflevocetirizine dihydrochloride usp, 5 mgLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralTopco Associates, LLC76162-91576162-0915-3576162-0915-80
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-39172288-0391-0172288-0391-78
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1CapsuleOralCARDINAL HEALTH 110, LLC. DBA LEADER70000-077170000-0771-0170000-0771-02
Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-78472288-0784-27
Allergy ReliefloratadineLoratadine 10 mg/1Tablet, Orally disintegratingOralMeijer, Inc.79481-972379481-9723-01
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralDr. Reddy's Laboratories Inc.75907-43475907-0434-0175907-0434-30
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralKroger Company30142-85630142-0856-62
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-04084324-0040-01
Allergy Reliefcetirizine tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDISCOUNT DRUG MART, INC53943-13053943-0130-1353943-0130-17

All 272 Allergy Relief NDCs

Other NDCs under ANDA 209274

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

FDA NDC Directory listings under ANDA 209274
ProductStrengthForm · routeLabelerProduct NDC
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGrocery Outlet, Inc85828-194
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralBi-Mar37835-611
All Day Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralStrategic Sourcing Services LLC70677-0057
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralLIDL US LLC71141-294
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-091
CetirizinecetiirizineCetirizine hydrochloride 10 mg/1TabletOralCVS PHARMACY, INC51316-764
Crcle Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-250
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralAdvanced Rx LLC80513-731
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules Pharmaceuticals Inc.70010-163
ValuMeds 24-Hour Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralCabinet Health P.B.C.82725-1003
CABINET Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-0119
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-9733
ValuMeds Cetirizine 10mgcetirizine 10mgCetirizine hydrochloride 10 mg/1TabletOralCabinet Health82725-1203
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralCVS PHARMACY, INC51316-806
Cetirizine Hydrochloride 10 Mgcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralYYBA CORP73581-202
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules India Ltd62207-764
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-4230
Allergy ReliefCetirizine hydrochloride 10 mg/1TabletOralDemoulas Super Markets, Inc.53942-396
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-4219
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralStrategic Sourcing Services LLC70677-1047

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