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 DirectoryProduct NDC (as listed)51660-491Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51660-0491Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-491-69 | 5166004916951660049169 | 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.NDC labeler code 51660
- 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_5daa16dc-fee3-7265-e063-6394a90a4e7eSPL ID 5daa16dc-fee3-7265-e063-6394a90a4e7e
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 51660-491
- What is NDC 51660-491?
- 51660-491 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 Ohm Laboratories Inc.. 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?
- Ohm Laboratories Inc., NDC labeler code 51660. 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. | 51660-724 | 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 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-048 | 85766-0048-10 |
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 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 |
| Loratadine and Pseudoephedrine | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-048 |
| 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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