NDC codes

FDA NDC Directory
Product NDC (as listed)49035-841Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0841Add 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
49035-841-25490350841251 BOTTLE in 1 BOX (49035-841-25) / 25 CAPSULE in 1 BOTTLEMarketed from Mar 31, 2018

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
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207235
Marketing start
Marketing end
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 49035-841_b808e3da-f23f-4ba1-970e-430bf2e204baSPL ID b808e3da-f23f-4ba1-970e-430bf2e204baSPL set ID d1703629-a641-403f-b547-032a75489d09RxCUI 1014675UNII 64O047KTOAUPC 0681131276733
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

N449035084125 followed by a unit qualifier and the quantity

Package 49035-0841-25. 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 207235

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

FDA NDC Directory listings under ANDA 207235
ProductStrengthForm · routeLabelerProduct NDC
basic care all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-007
CareOne Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralAmerican Sales Company41520-715
top care all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralTopco Associates LLC36800-180
dg health all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralDolgencorp, LLC55910-710
All Day Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1CapsuleOralP & L Development, LLC59726-741
24 hour allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Capsule, Liquid filledOralMeijer Distribution Inc41250-618

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