Over-the-counter drug · ANDA
Wal-Zyr D NDC 0363-0989
cetirizine hydrochloride and pseudoephedrine hydrochloride · Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0989-12 | 0036309891200363098912 | 2 BLISTER PACK in 1 CARTON (0363-0989-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Nov 1, 2018 | |
| 0363-0989-24 | 0036309892400363098924 | 4 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
N400363098912followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 70677-1020 |
| Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | RITE AID | 11822-9994 |
| Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CHAIN DRUG CONSORTIUM,LLC | 68016-531 |
| Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Ohm Laboratories Inc. | 51660-940 |
| Allergy Relief-Dcetirizine hydrochloride and pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | CVS PHARMACY | 69842-994 |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 62756-915 |