Over-the-counter drug · ANDA
Loratadine and Pseudoephedrine NDC 51660-491
Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 · Tablet, Extended release · Oral · Ohm Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-491-69 | 51660049169 | 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-491-69)Marketed from Jan 15, 2020 |
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
- Ohm Laboratories Inc.
- 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 51660-491_39f4d9f5-7448-2a58-e063-6394a90a44b1SPL ID 39f4d9f5-7448-2a58-e063-6394a90a44b1SPL set ID bbe83464-a582-469f-8fac-f98e804d96feRxCUI 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
N451660049169followed by a unit qualifier and the quantityPackage 51660-0491-69. 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.
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 | Major Pharmaceuticals | 0904-5833 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | STRATEGIC SOURCING SERVICES LLC | 70677-1018 |
| 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, 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 | 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 Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-048 |
| 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 | 37808-427 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-0725 |
| 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 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, Extended releaseOral | WAL-MART STORES, INC | 49035-488 |
| 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 | Safeway Inc. | 21130-724 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | AMERISOURCE BERGEN | 46122-383 |
| 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 Pseudoephedrineloratadine and pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Rite Aid | 11822-9990 |
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