Over-the-counter drug · NDA
Claritin-D 24 Hour (Loratadine and pseudoephedrine sulfate) NDC 11523-4332
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 |
|---|---|---|---|
| 11523-4332-1 | 1152343320111523433201 | 1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009 | |
| 11523-4332-2 | 1152343320211523433202 | 1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009 | |
| 11523-4332-3 | 1152343320311523433203 | 3 BLISTER PACK in 1 CARTON (11523-4332-3) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009 |
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 and pseudoephedrine sulfate
- Active ingredients
- Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.NDC labeler code 11523
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020470
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 11523-4332_45370575-1a5d-c6f1-e063-6394a90a24c4SPL ID 45370575-1a5d-c6f1-e063-6394a90a24c4SPL set ID f046a807-ab8c-0620-e053-2a95a90a9d3cRxCUI 1117562, 1242391UNII 7AJO3BO7QN, Y9DL7QPE6BUPC 0041100810861
- 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
N411523433201followed by a unit qualifier and the quantityPackage 11523-4332-01. 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.
About NDC 11523-4332
- What is NDC 11523-4332?
- 11523-4332 is the product NDC for Claritin-D 24 Hour, Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 tablet, extended release, listed with the FDA by Bayer HealthCare LLC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Claritin-D 24 Hour (Loratadine and pseudoephedrine sulfate).
- What is the active ingredient?
- Loratadine, Pseudoephedrine sulfate.
- Who is the labeler?
- Bayer HealthCare LLC., NDC labeler code 11523. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Claritin-D 24 Hour?
- 1 other product NDC are listed under this name. See all Claritin-D 24 Hour NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Claritin-D 24 Hour products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Claritin-D 24 Hourloratadine pseudoephedrine sulfate | Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 | Tablet, Extended releaseOral | Bayer HealthCare LLC. | 11523-0102 | 11523-0102-0111523-0102-02 |