Over-the-counter drug · ANDA
allergy relief d 12 (Loratadine, pseudoephedrine sulfate) NDC 0363-7023
Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-7023-46 | 00363702346 | 10 BLISTER PACK in 1 CARTON (0363-7023-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 6, 2023 | |
| 0363-7023-60 | 00363702360 | 20 BLISTER PACK in 1 CARTON (0363-7023-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 20, 2021 | |
| 0363-7023-65 | 00363702365 | 30 BLISTER PACK in 1 CARTON (0363-7023-65) / 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 d 12
- Generic name (nonproprietary)
- loratadine, pseudoephedrine sulfate
- Active ingredients
- Loratadine — 5 mg/1Pseudoephedrine sulfate — 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 076050
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 0363-7023_d94eb2ec-8cdf-465e-a5f9-db3f8a3e6c1fSPL ID d94eb2ec-8cdf-465e-a5f9-db3f8a3e6c1fSPL set ID 7e6ea563-cc79-4683-b600-0691e0fb78abRxCUI 1242399UNII 7AJO3BO7QN, Y9DL7QPE6B
- Pharmacologic class
- 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
N400363702346followed by a unit qualifier and the quantityPackage 00363-7023-46. 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: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • 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 0363-7023
- What is NDC 0363-7023?
- 0363-7023 is the product NDC for allergy relief d 12, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Walgreen Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- allergy relief d 12 (Loratadine, Pseudoephedrine sulfate).
- What is the active ingredient?
- Loratadine, Pseudoephedrine sulfate.
- 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 allergy relief d 12?
- 1 other product NDC are listed under this name. See all allergy relief d 12 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other allergy relief d 12 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| allergy relief d 12loratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 69842-641 | 69842-0641-4669842-0641-6069842-0641-65 |
Other NDCs under ANDA 076050
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 |
|---|---|---|---|---|
| Alavert Allergy and Congestion D-12 hourloratadine and pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Foundation Consumer Brands | 80070-100 |
| Allergy and Congestion Reliefloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-2007 |
| allergy and nasal congestionloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Kroger Company | 30142-850 |
| allergy relief dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution Inc | 41250-954 |
| allergy relief dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Publix Super Markets Inc | 56062-555 |
| allergy relief d 12loratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 69842-641 |
| equate allergy and congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Wal-Mart Stores Inc | 49035-643 |
| foster and thrive allergy D 12 hourloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1024 |
| good neighbor pharmacy loratadine dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Amerisource Bergen | 46122-455 |
| kirkland signature allerclear d 12 hrloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Costco Wholesale Company | 63981-723 |
| Leader Allergy Relief D12loratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0504 |
| loratadine Dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-122 |
| loratadine Dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Sportpharm LLC | 85766-047 |
| perrigo allergy dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-7777 |
| signature care allergy and congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Safeway | 21130-482 |
| topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-611 |