Over-the-counter drug · ANDA

Medline (Cetirizine hcl) NDC 53329-033

Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-033Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0033Add 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
53329-033-33533290033335332900333330 TABLET in 1 BOTTLE (53329-033-33)Marketed from May 1, 2020
53329-033-38533290033385332900333890 TABLET in 1 BOTTLE (53329-033-38)Marketed from May 1, 2020

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)
Medline
Generic name (nonproprietary)
cetirizine hcl
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Medline Industries, LPNDC labeler code 53329
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
Marketing start
Marketing end
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 53329-033_536f7c99-48c2-9a94-e063-6294a90a5969SPL ID 536f7c99-48c2-9a94-e063-6294a90a5969SPL set ID a75cd557-e19b-fdd4-e053-2a95a90a8097RxCUI 1014678UNII 64O047KTOAUPC 0193489019769
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

N453329003333 followed by a unit qualifier and the quantity

Package 53329-0033-33. 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 53329-033

What is NDC 53329-033?
53329-033 is the product NDC for Medline (cetirizine hcl), Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Medline Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Medline (Cetirizine hcl).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Medline?
46 other product NDCs are listed under this name. See all Medline 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 Medline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MedlineacetaminophenAcetaminophen 325 mg/1TabletOralMedline Industries, LP53329-19953329-0199-09
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-22153329-0221-09
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-60353329-0603-09
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60553329-0605-09
Medlinemiconazole nitrateMiconazole nitrate 20 mg/gOintmentTopicalMedline Industries, LP53329-25653329-0256-1453329-0256-64
MedlineacetaminophenAcetaminophen 500 mg/1TabletOralMedline Industries, LP53329-60453329-0604-30
MedlinedimethiconeDimethicone 1.575 g/100mLCreamTopicalMedline Industries, LP53329-27153329-0271-4453329-0271-86
MedlineaspirinAspirin 81 mg/1Tablet, Delayed releaseOralMedline Industries, LP53329-60053329-0600-67
Medlinewhite petrolatumWhite petrolatum 86.5 g/100gOintmentTopicalMedline Industries, LP53329-25753329-0257-1053329-0257-74
Medlinezinc oxideZinc oxide 200 mg/gPasteTopicalMedline Industries, LP53329-25553329-0255-0553329-0255-10

All 47 Medline 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
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, CoatedOralAAA PHARMACEUTICAL, INC.57344-194
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

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