NDC codes

FDA NDC Directory
Product NDC (as listed)53943-219Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0219Add 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
53943-219-40539430219401 BOTTLE in 1 CARTON (53943-219-40) / 40 CAPSULE in 1 BOTTLEMarketed from Aug 2, 2019

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 hcl
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Capsule
Route
Oral
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022429
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 53943-219_f0ff6c1c-a2cf-11d1-e053-2a95a90adb24SPL ID f0ff6c1c-a2cf-11d1-e053-2a95a90adb24SPL set ID 89c77f0d-a325-4f8f-9142-98c0d41de8b1RxCUI 1014675UNII 64O047KTOAUPC 0093351030123
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

N453943021940 followed by a unit qualifier and the quantity

Package 53943-0219-40. 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 NDA 022429

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

FDA NDC Directory listings under NDA 022429
ProductStrengthForm · routeLabelerProduct NDC
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralNortheast Pharma80136-856
24 Hour Allergycetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralWalgreens0363-1219
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralMeijer Distribution Inc79481-0670
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralMeijer Distribution Inc79481-0671
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralTOP CARE (Topco Associates LLC)36800-542
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralTOP CARE (Topco Associates LLC)36800-543
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralBionpharma Inc.69452-479
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralAMERISOURCE BERGEN46122-815
all day allergycetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralSUPERVALU INC41163-219
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralCVS Pharmacy51316-900
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralKROGER COMPANY30142-995
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralKROGER COMPANY59450-020
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralWhole Foods Market, INC.42681-0056
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralTARGET Corporation11673-242
All Day Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralCHAIN DRUG MARKETING ASSOCIATION INC.63868-433
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralPUBLIX SUPER MARKETS INC56062-452
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralPUBLIX SUPER MARKETS INC56062-495
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralDOLGENCORP INC55910-784
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralAMERISOURCE BERGEN46122-613
Cetirizine HClCetirizine hydrochloride 10 mg/1CapsuleOralBionpharma Inc.69452-265

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