NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0989Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0989Add 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
0363-0989-1200363098912003630989122 BLISTER PACK in 1 CARTON (0363-0989-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 1, 2018
0363-0989-2400363098924003630989244 BLISTER PACK in 1 CARTON (0363-0989-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 1, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Wal-Zyr D
Generic name (nonproprietary)
cetirizine hydrochloride and pseudoephedrine hydrochloride
Active ingredients
Cetirizine hydrochloride — 5 mg/1Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090922
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0363-0989_8b190a22-48f3-4ec7-b0de-2879e66e9358SPL ID 8b190a22-48f3-4ec7-b0de-2879e66e9358SPL set ID 778ba62e-6cce-4d0f-b6d9-48b35ef40da7RxCUI 1014571, 1014580UNII 64O047KTOA, 6V9V2RYJ8N
Pharmacologic class
Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist

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

N400363098912 followed by a unit qualifier and the quantity

Package 00363-0989-12. 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 nose or throat nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-0989

What is NDC 0363-0989?
0363-0989 is the product NDC for Wal-Zyr D, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Wal-Zyr D (Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride, Pseudoephedrine hydrochloride.
Who is the labeler?
Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Wal-Zyr D?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 090922

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

FDA NDC Directory listings under ANDA 090922
ProductStrengthForm · routeLabelerProduct NDC
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1020
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-9994
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCHAIN DRUG CONSORTIUM,LLC68016-531
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralOhm Laboratories Inc.51660-940
Allergy Relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralCVS PHARMACY69842-994
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSun Pharmaceutical Industries, Inc.62756-915

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