Prescription drug · NDA
Clarinex-D 12 Hour NDC 78206-120
desloratadine and pseudoephedrine sulfate · Desloratadine 2.5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Extended release · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-120-01 | 7820601200178206012001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)Marketed from Jun 1, 2021 |
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)
- Clarinex-D 12 Hour
- Generic name (nonproprietary)
- desloratadine and pseudoephedrine sulfate
- Active ingredients
- Desloratadine — 2.5 mg/1Pseudoephedrine sulfate — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021313
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 78206-120_64c0d4d8-2434-45c4-801e-710026c5b07fSPL ID 64c0d4d8-2434-45c4-801e-710026c5b07fSPL set ID 1af66b7a-4ab8-40d8-abdd-22d3310228a8RxCUI 1112248, 1112250UNII FVF865388R, Y9DL7QPE6B
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N478206012001followed by a unit qualifier and the quantityPackage 78206-0120-01. 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)
CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. ( 1.1 ) 1.1 Seasonal Allergic Rhinitis CLARINEX-D ® 12 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. CLARINEX-D 12 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant p…
Excerpt only. Read the full label for complete information.
About NDC 78206-120
- What is NDC 78206-120?
- 78206-120 is the product NDC for Clarinex-D 12 Hour, Desloratadine 2.5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, extended release, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clarinex-D 12 Hour (Desloratadine and pseudoephedrine sulfate).
- What is the active ingredient?
- Desloratadine, Pseudoephedrine sulfate.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clarinex-D 12 Hour?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.