Over-the-counter drug · ANDA

Allergy Relief (Cetirizine hydrochloride) NDC 61504-194

Cetirizine hydrochloride 10 mg/1 · Tablet, Coated · Oral · Amerifoods Trading Company

NDC codes

FDA NDC Directory
Product NDC (as listed)61504-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61504-0194Add 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
61504-194-14615040194141 BOTTLE, PLASTIC in 1 CARTON (61504-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 30, 2023
61504-194-16615040194161 BOTTLE, PLASTIC in 1 CARTON (61504-194-16) / 90 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 30, 2023

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
Amerifoods Trading CompanyNDC labeler code 61504
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 61504-194_092d4666-dc93-1c0f-e063-6294a90a7aafSPL ID 092d4666-dc93-1c0f-e063-6294a90a7aafSPL set ID f6ce3cdf-2e6d-61e8-e053-6294a90af7d3RxCUI 1014678UNII 64O047KTOAUPC 0041512177781
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

N461504019414 followed by a unit qualifier and the quantity

Package 61504-0194-14. 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 61504-194

What is NDC 61504-194?
61504-194 is the product NDC for Allergy Relief (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Amerifoods Trading Company. It has 2 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?
Amerifoods Trading Company, NDC labeler code 61504. 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?
263 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 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
Allergy Relieffluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalP & L Development, LLC59726-20359726-0203-3859726-0203-54

All 264 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
ValuMeds Cetirizine 10mgcetirizine 10mgCetirizine hydrochloride 10 mg/1TabletOralCabinet Health82725-1203
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-091
CABINET Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-0119
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralStrategic Sourcing Services LLC70677-1047
CetirizinecetiirizineCetirizine hydrochloride 10 mg/1TabletOralCVS PHARMACY, INC51316-764
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-197
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules Pharmaceuticals Inc.70010-163
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-4219
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-4230
Medlinecetirizine hclCetirizine hydrochloride 10 mg/1TabletOralMedline Industries, LP53329-033
Crcle Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-250
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralStrive Pharmaceuticals Inc70692-139
ValuMeds 24-Hour Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralCabinet Health P.B.C.82725-1003
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralCVS PHARMACY, INC51316-806
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralRETAIL BUSINESS SERVICES , LLC.72476-194
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralPioneer Life Sciences, LLC72090-059
Cetirizine hydrochloride - HIVEScetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules Pharmaceuticals Inc.70010-293
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralFamily Dollar (FAMILY WELLNESS)55319-962
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules India Ltd62207-764
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralAdvanced Rx LLC80513-731

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