Over-the-counter drug · ANDA
loratadine D (Loratadine, pseudoephedrine sulfate) NDC 85766-047
Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-047-10 | 8576600471085766004710 | 10 BLISTER PACK in 1 CARTON (85766-047-10) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 2, 2025 |
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)
- loratadine D
- 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
- Sportpharm LLCNDC labeler code 85766
- 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 85766-047_4a2c3181-73fa-906a-e063-6294a90a6479SPL ID 4a2c3181-73fa-906a-e063-6294a90a6479SPL set ID bb54f613-b2ab-48fd-83c9-2038ec7097f6RxCUI 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
N485766004710followed by a unit qualifier and the quantityPackage 85766-0047-10. 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 85766-047
- What is NDC 85766-047?
- 85766-047 is the product NDC for loratadine D, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Sportpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- loratadine D (Loratadine, Pseudoephedrine sulfate).
- What is the active ingredient?
- Loratadine, Pseudoephedrine sulfate.
- Who is the labeler?
- Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for loratadine D?
- 1 other product NDC are listed under this name. See all loratadine D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other loratadine D products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| loratadine Dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-122 | 45802-0122-4645802-0122-6045802-0122-65 |
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 | Walgreen Company | 0363-7023 |
| 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 |
| 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 |