Over-the-counter drug · ANDA
loratadine D (Loratadine, pseudoephedrine sulfate) NDC 45802-122
Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-122-46 | 4580201224645802012246 | 10 BLISTER PACK in 1 CARTON (45802-122-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 10, 2018 | |
| 45802-122-60 | 4580201226045802012260 | 20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 10, 2018 | |
| 45802-122-65 | 4580201226545802012265 | 30 BLISTER PACK in 1 CARTON (45802-122-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 10, 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)
- loratadine D
- 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
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- 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 45802-122_64fa8aa8-ec51-4129-88d1-b1a8651061f6SPL ID 64fa8aa8-ec51-4129-88d1-b1a8651061f6SPL set ID 01e61c73-3b81-4683-b1a9-8784c0d565b1RxCUI 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
N445802012246followed by a unit qualifier and the quantityPackage 45802-0122-46. 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 45802-122
- What is NDC 45802-122?
- 45802-122 is the product NDC for loratadine D, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- loratadine D (Loratadine, Pseudoephedrine sulfate).
- What is the active ingredient?
- Loratadine, Pseudoephedrine sulfate.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 D?
- 1 other product NDC are listed under this name. See all loratadine D NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other loratadine D 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 Dloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Sportpharm LLC | 85766-047 | 85766-0047-10 |
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 | 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 |
| topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-611 |