Over-the-counter drug · ANDA
topcare allergy and congestion relief (Loratadine, pseudoephedrine sulfate) NDC 36800-611
Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-611-65 | 3680006116536800061165 | 30 BLISTER PACK in 1 CARTON (36800-611-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 18, 2018 |
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)
- topcare allergy and congestion relief
- 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
- Topco Associates LLCNDC labeler code 36800
- 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 36800-611_47f02151-689c-4592-ab13-6c4e259d7a6cSPL ID 47f02151-689c-4592-ab13-6c4e259d7a6cSPL set ID dd93d172-2a3a-4e4c-a237-7668acbd537dRxCUI 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
N436800061165followed by a unit qualifier and the quantityPackage 36800-0611-65. 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 36800-611
- What is NDC 36800-611?
- 36800-611 is the product NDC for topcare allergy and congestion relief, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare allergy and congestion relief (Loratadine, pseudoephedrine sulfate).
- What is the active ingredient?
- Loratadine, Pseudoephedrine sulfate.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare allergy and congestion relief?
- 1 other product NDC are listed under this name. See all topcare allergy and congestion relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare allergy and congestion relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Topco Associates LLC | 36800-706 | 36800-0706-22 |
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 |
| loratadine Dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Sportpharm LLC | 85766-047 |
| 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 |