Over-the-counter drug · NDA
Claritin-D 12 Hour NDC 11523-7162
loratadine and pseudoephedrine sulfate · Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Extended release · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-7162-1 | 11523716201 | 1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009 | |
| 11523-7162-2 | 11523716202 | 2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009 | |
| 11523-7162-3 | 11523716203 | 3 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 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 12 HourSuffix: 12 Hour
- Generic name (nonproprietary)
- loratadine and pseudoephedrine sulfate
- Active ingredients
- Loratadine — 5 mg/1Pseudoephedrine sulfate — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bayer HealthCare LLC.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019670
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 11523-7162_45371982-daab-f344-e063-6394a90a2f41SPL ID 45371982-daab-f344-e063-6394a90a2f41SPL set ID a7125705-01ff-4418-8c53-9209c2bbb484RxCUI 1242399, 1242406UNII 7AJO3BO7QN, Y9DL7QPE6BUPC 0041100802088
- 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
N411523716201followed by a unit qualifier and the quantityPackage 11523-7162-01. 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.