Over-the-counter drug · ANDA

ZYRTEC Allergy (Cetirizine hydrochloride) NDC 50580-786

Cetirizine hydrochloride 10 mg/1 · Capsule, Liquid filled · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-786Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0786Add 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
50580-786-1250580078612505800786121 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Apr 15, 2024
50580-786-1350580078613505800786131 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 1, 2024
50580-786-2550580078625505800786251 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Apr 15, 2024
50580-786-2650580078626505800786261 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 1, 2024
50580-786-4050580078640505800786401 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Apr 15, 2024
50580-786-4150580078641505800786411 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Dec 1, 2024
50580-786-65505800786655058007866565 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65)Marketed from Apr 15, 2024
50580-786-66505800786665058007866665 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66)Marketed from Dec 1, 2024

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)
ZYRTEC Allergy
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213105
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87SPL ID 41a5a9a1-61a6-f771-e063-6294a90aed87SPL set ID 0face45c-af24-3559-e063-6294a90abde5RxCUI 1014675, 1020023UNII 64O047KTOAUPC 0300450204318
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

N450580078612 followed by a unit qualifier and the quantity

Package 50580-0786-12. 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 50580-786

What is NDC 50580-786?
50580-786 is the product NDC for ZYRTEC Allergy (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 capsule, liquid filled, listed with the FDA by Kenvue Brands LLC. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ZYRTEC Allergy (Cetirizine Hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ZYRTEC Allergy?
9 other product NDCs are listed under this name. See all ZYRTEC Allergy 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 ZYRTEC Allergy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSavings Distributors LLC73097-01673097-0016-20
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMorning Star OTC53209-500153209-5001-01
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 5 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-75450580-0754-1550580-0754-35
Zyrtec Allergycetirizine hydrochloride—KitKenvue Brands LLC50580-75250580-0752-01
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralNavajo Manufacturing Company Incorporated67751-19267751-0192-01
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Orally disintegratingOralKenvue Brands LLC50580-77850580-0778-24
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralKenvue Brands LLC50580-72650580-0726-0350580-0726-0550580-0726-25+19 more
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralRedPharm Drug Inc67296-148467296-1484-03
Zyrtec Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSelect Consumer Group85237-296085237-2960-0185237-2960-03

Other NDCs under ANDA 213105

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

FDA NDC Directory listings under ANDA 213105
ProductStrengthForm · routeLabelerProduct NDC
All Day Allergycetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralWALMART INC. (see also Equate)79903-084
All Day Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralP & L Development, LLC59726-064
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralSafeway, Inc.21130-364
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralH E B37808-564
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralCVS PHARMACY, INC51316-064
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralCVS PHARMACY, INC51316-810
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralCVS PHARMACY, INC51316-811
allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralPublix Super Markets Inc56062-111
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralCare One (Retail Business Services, LLC.)72476-064
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralWALMART INC. (see also Equate)79903-347
basic care all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-980
careone allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralRetail Business Services, LLC72476-623
dg health all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralDolgencorp Inc55910-934
Good Sense All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralL. Perrigo Company0113-0981
topcare all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralTopco Associates LLC36800-448
Zyrtec Allergy Cetirizine HClcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1CapsuleOralJones Healthcare Group - Packaging Services, Inc67414-012
Zyrtec Allergy Cetirizine HClcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1CapsuleOralJones Healthcare Group - Packaging Services, Inc67414-013

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