Over-the-counter drug · ANDA

Crcle Cetirizine Hydrochloride (cetirizine hydrochloride) NDC 57483-250

Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Innovus Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)57483-250Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57483-0250Add 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
57483-250-0157483025001365 TABLET in 1 CONTAINER (57483-250-01)Marketed from Apr 28, 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)
Crcle Cetirizine Hydrochloride
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
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 57483-250_b1644d9c-353b-44bf-b3f9-9bd8b83976f2SPL ID b1644d9c-353b-44bf-b3f9-9bd8b83976f2SPL set ID 640583b6-379d-4ad3-b00c-383377c54eedRxCUI 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

N457483025001 followed by a unit qualifier and the quantity

Package 57483-0250-01. 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)

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 hclCetirizine hydrochloride 10 mg/1TabletOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-930
CABINET Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-0119
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-4219
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSpirit Pharmaceutical LLC68210-4230
CetirizinecetiirizineCetirizine hydrochloride 10 mg/1TabletOralCVS PHARMACY, INC51316-764
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralRETAIL BUSINESS SERVICES , LLC.72476-194
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralStrategic Sourcing Services LLC70677-1047
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralAdvanced Rx LLC80513-731
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralStrive Pharmaceuticals Inc70692-139
Medlinecetirizine hclCetirizine hydrochloride 10 mg/1TabletOralMedline Industries, LP53329-033
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules India Ltd62207-764
Cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules Pharmaceuticals Inc.70010-163
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralSAFEWAY21130-640
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralFamily Dollar (FAMILY WELLNESS)55319-962
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-197
Allergy Reliefcetirizine hcl 10 mgCetirizine hydrochloride 10 mg/1TabletOralAllegiant Health69168-396
Curist Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralLittle Pharma, Inc.72559-003
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralRETAIL BUSINESS SERVICES,LLC.72476-764
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralFSA STORE INC.81522-194
Cetirizine hydrochloride - HIVEScetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralGranules Pharmaceuticals Inc.70010-293

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