NDC codes

FDA NDC Directory
Product NDC (as listed)11523-7162Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11523-7162Add 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
11523-7162-111523716201115237162011 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009
11523-7162-211523716202115237162022 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Dec 1, 2009
11523-7162-311523716203115237162033 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.NDC labeler code 11523
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

N411523716201 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 11523-7162

What is NDC 11523-7162?
11523-7162 is the product NDC for Claritin-D 12 Hour, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 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 12 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 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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