Over-the-counter drug · ANDA
signature care allergy relief d NDC 21130-644
cetirizine hydrochloride, pseudoephedrine hydrochloride · Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Safeway
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-644-62 | 2113006446221130064462 | 24 BLISTER PACK in 1 CARTON (21130-644-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 16, 2021 |
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)
- signature care allergy relief d
- 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
- SafewayNDC labeler code 21130
- 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 21130-644_e96874ea-3391-4837-a50e-4546a72e9278SPL ID e96874ea-3391-4837-a50e-4546a72e9278SPL set ID 8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c80RxCUI 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
N421130064462followed by a unit qualifier and the quantityPackage 21130-0644-62. 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 • 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 21130-644
- What is NDC 21130-644?
- 21130-644 is the product NDC for signature care allergy relief d, Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- signature care allergy relief d (Cetirizine hydrochloride, pseudoephedrine hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for signature care allergy relief 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 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 |
|---|---|---|---|---|
| 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 relief D12cetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-4923 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |