NDC codes

FDA NDC Directory
Product NDC (as listed)78206-120Labeler and product segments. Claims need a package NDC.
Product NDC at billing width78206-0120Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
78206-120-017820601200178206012001100 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

N478206012001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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