Over-the-counter drug · ANDA
Loratadine and Pseudoephedrine NDC 85766-048
Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 · Tablet, Extended release · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-048-10 | 8576600481085766004810 | 1 BLISTER PACK in 1 CARTON (85766-048-10) / 10 TABLET, 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 and Pseudoephedrine
- Generic name (nonproprietary)
- loratadine and pseudoephedrine
- Active ingredients
- Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
- Dosage form
- Tablet, 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 076557
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 85766-048_4a2c2629-df77-dec0-e063-6394a90a45a4SPL ID 4a2c2629-df77-dec0-e063-6394a90a45a4SPL set ID 2b432b67-f9f3-45e2-8306-2d4080152f99RxCUI 1117562UNII 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
N485766004810followed by a unit qualifier and the quantityPackage 85766-0048-10. 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 reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
About NDC 85766-048
- What is NDC 85766-048?
- 85766-048 is the product NDC for Loratadine and Pseudoephedrine, Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 tablet, 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 and Pseudoephedrine.
- 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 and Pseudoephedrine?
- 7 other product NDCs are listed under this name. See all Loratadine and Pseudoephedrine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loratadine and Pseudoephedrine 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 and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 70677-1018 | 70677-1018-0170677-1018-02 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | AMERISOURCE BERGEN | 46122-383 | 46122-0383-22 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-0725 | 00363-0725-1500363-0725-5600363-0725-69 |
| Loratadine and Pseudoephedrineloratadine and pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Rite Aid | 11822-9990 | 11822-9990-0011822-9990-05 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories Inc. | 51660-491 | 51660-0491-69 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories Inc. | 51660-724 | 51660-0724-0451660-0724-1551660-0724-69 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-305 | 63187-0305-10 |
Other NDCs under ANDA 076557
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 |
|---|---|---|---|---|
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | STRATEGIC SOURCING SERVICES | 49348-543 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Safeway Inc. | 21130-724 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-5833 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-0725 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | AMERISOURCE BERGEN | 46122-383 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 70677-1018 |
| KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Releaseloratadine and pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Kirkland-COSTCO WHOLESALE COMPANY | 63981-724 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories Inc. | 51660-491 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Strategic Sourcing Services LLC | 62011-0071 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Strategic Sourcing Services LLC | 62011-0071 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-305 |
| Loratadine and Pseudoephedrineloratadine and pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Rite Aid | 11822-9990 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Ohm Laboratories Inc. | 51660-724 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | HEB | 37808-724 |
| Allergy Relief-Dloratadine and pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | CVS Pharmacy | 59779-726 |
| Leader Allergy Relief D-24loratadine and pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health | 70000-0162 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Amerisource Bergen | 46122-167 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution, Inc. | 41250-724 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | The Kroger Company | 30142-724 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | WAL-MART STORES, INC | 49035-488 |
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