Over-the-counter drug · ANDA
allergy d NDC 0113-9004
loratadine, pseudoephedrine sulfate · Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 · Tablet, Extended release · Oral · L. Perrigo Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0113-9004-22 | 00113900422 | 15 BLISTER PACK in 1 CARTON (0113-9004-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 3, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- allergy d
- Generic name (nonproprietary)
- loratadine, pseudoephedrine sulfate
- Active ingredients
- Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- L. Perrigo Company
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075989
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 0113-9004_512f8f46-5c62-470d-b14a-93b86ec34ce8SPL ID 512f8f46-5c62-470d-b14a-93b86ec34ce8SPL set ID 512f8f46-5c62-470d-b14a-93b86ec34ce8RxCUI 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
N400113900422followed by a unit qualifier and the quantityPackage 00113-9004-22. 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.
Other NDCs under ANDA 075989
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 |
|---|---|---|---|---|
| kirkland signature allerclear d 24 hrloratadine, pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Costco Wholesale Company | 63981-138 |
| Allergy Relief Dloratadine, pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Walgreen Company | 0363-2010 |
| allergy congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Kroger Company | 30142-846 |
| topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Topco Associates LLC | 36800-706 |