Over-the-counter drug · ANDA
Claritin-D 24 Hour (loratadine pseudoephedrine sulfate) NDC 11523-0102
Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 · Tablet, Extended release · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-0102-1 | 11523010201 | 1 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 12, 2022 | |
| 11523-0102-2 | 11523010202 | 1 BLISTER PACK in 1 CARTON (11523-0102-2) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 12, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Claritin-D 24 HourSuffix: 24 Hour
- Generic name (nonproprietary)
- loratadine pseudoephedrine sulfate
- Active ingredients
- Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075706
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 11523-0102_4526d9ef-02fb-338e-e063-6394a90af108SPL ID 4526d9ef-02fb-338e-e063-6394a90af108SPL set ID 3ea6a90b-8cb1-46b0-9ff7-be7090245e53RxCUI 1117562, 1242391UNII 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
N411523010201followed by a unit qualifier and the quantityPackage 11523-0102-01. 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 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.