Over-the-counter drug · ANDA
allergy relief D12 NDC 0363-4923
cetirizine hydrochloride, pseudoephedrine hydrochloride · Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-4923Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-4923Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-4923-53 | 00363492353 | 12 BLISTER PACK in 1 CARTON (0363-4923-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 20, 2021 | |
| 0363-4923-62 | 00363492362 | 24 BLISTER PACK in 1 CARTON (0363-4923-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 20, 2021 |
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)
- allergy relief D12
- Generic name (nonproprietary)
- cetirizine hydrochloride, pseudoephedrine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/1Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Walgreen Company
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210719
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0363-4923_7b2562f7-d202-464a-a703-65d77a49031aSPL ID 7b2562f7-d202-464a-a703-65d77a49031aSPL set ID aa515879-9851-4915-bd41-51d81e585dd7RxCUI 1014571UNII 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
N400363492353followed by a unit qualifier and the quantityPackage 00363-4923-53. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210719
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 |
|---|---|---|---|---|
| Foster And Thrive All Day Allergy Dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1311 |
| 12 hour allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution Inc | 41250-728 |
| Leader Allergy Relief Dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0042 |
| allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 69842-415 |
| signature care allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Safeway | 21130-644 |
| allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Publix Super Markets Inc | 56062-147 |
| topcare all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-744 |
| Cetirizine hydrochloride and Pseudoephedrine hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-147 |
| allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | H E B | 37808-651 |
| kirkland signature aller tec dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Costco Wholesale Company | 63981-147 |
| equate allergy relief d nasal decongestantcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | WALMART INC. | 79903-126 |
| all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Kroger Company | 30142-450 |
| Allergy Relief D12cetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-607 |
| good neighbor pharmacy all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Amerisource Bergen | 46122-626 |
| All Day Allergy Dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-2147 |
| Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloridecetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rugby Laboratories | 0536-1279 |
| good sense all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-0147 |
| Allergy and Sinus Reliefcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Kroger Company | 30142-633 |
| allergy relief-Dcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Rite Aid Corporation | 11822-3009 |