Over-the-counter drug · ANDA
Loratadine and Pseudoephedrine Sulfate NDC 49348-543
Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 · Tablet, Film coated, Extended release · Oral · STRATEGIC SOURCING SERVICES
NDC codes
FDA NDC DirectoryProduct NDC (as listed)49348-543Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49348-0543Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49348-543-01 | 4934805430149348054301 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (49348-543-01)Marketed from Nov 17, 2004 | |
| 49348-543-57 | 4934805435749348054357 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (49348-543-57)Marketed from Nov 17, 2004 |
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 Sulfate
- Generic name (nonproprietary)
- loratadine and pseudoephedrine sulfate
- Active ingredients
- Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- STRATEGIC SOURCING SERVICESNDC labeler code 49348
- 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 49348-543_6459b34c-2237-4931-af7a-507effd2daf0SPL ID 6459b34c-2237-4931-af7a-507effd2daf0SPL set ID 114b5e7c-973a-4a34-8538-a214de090b39RxCUI 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
N449348054301followed by a unit qualifier and the quantityPackage 49348-0543-01. 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 49348-543
- What is NDC 49348-543?
- 49348-543 is the product NDC for Loratadine and Pseudoephedrine Sulfate, Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 tablet, film coated, extended release, listed with the FDA by STRATEGIC SOURCING SERVICES. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine and Pseudoephedrine Sulfate.
- What is the active ingredient?
- Loratadine, Pseudoephedrine sulfate.
- Who is the labeler?
- STRATEGIC SOURCING SERVICES, NDC labeler code 49348. 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 Sulfate?
- 10 other product NDCs are listed under this name. See all Loratadine and Pseudoephedrine Sulfate 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 Sulfate 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 Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | WAL-MART STORES, INC | 49035-488 | 49035-0488-1549035-0488-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | HEB | 37808-427 | 37808-0427-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | HEB | 37808-724 | 37808-0724-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-5833 | 00904-5833-1500904-5833-48 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Safeway Inc. | 21130-724 | 21130-0724-1521130-0724-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | The Kroger Company | 30142-724 | 30142-0724-1530142-0724-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Meijer Distribution, Inc. | 41250-724 | 41250-0724-5241250-0724-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Amerisource Bergen | 46122-167 | 46122-0167-52 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Publix Super Markets Inc | 56062-724 | 56062-0724-1556062-0724-69 |
| Loratadine and Pseudoephedrine Sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Film coated, Extended releaseOral | Strategic Sourcing Services LLC | 62011-0071 | 62011-0071-01 |
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 | 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 |
| 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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