NDC codes

FDA NDC Directory
Product NDC (as listed)49035-106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0106Add 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
49035-106-08490350106081 BOTTLE in 1 CARTON (49035-106-08) / 120 mL in 1 BOTTLEMarketed from May 20, 2011

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)
Childrens Allergy ReliefSuffix: Allergy Relief
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 5 mg/5mL
Dosage form
Solution
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201546
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 49035-106_26f1efff-e30b-4c6b-b1d1-51be507fbef1SPL ID 26f1efff-e30b-4c6b-b1d1-51be507fbef1SPL set ID 0d026538-5708-4030-b65d-18790e72059aRxCUI 1014673UNII 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

N449035010608 followed by a unit qualifier and the quantity

Package 49035-0106-08. 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 201546

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

FDA NDC Directory listings under ANDA 201546
ProductStrengthForm · routeLabelerProduct NDC
Childrens Cetirzinecetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralPharmacy Value Alliance LLC68016-106
Wal-Zyr All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralWALGREEN COMPANY0363-2106
Childrens Allergycetirizine hydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralPublix Super Markets Inc56062-106
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralSun Pharmaceutical Industries, Inc.51672-2106
All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 5 mg/5mLSolutionOralAmerisource Bergen46122-101
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralH E B37808-106
Rite Aid childrens allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralRite Aid Corporation11822-2106

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