Claritin (loratadine) NDC 11523-4331

NDC codes

FDA NDC Directory

Product NDC (as listed)11523-4331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11523-4331Add 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 NDC	11-digit (billing)	Package
11523-4331-1	11523433101	4 BLISTER PACK in 1 CARTON (11523-4331-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Aug 23, 2006
11523-4331-2	11523433102	6 BLISTER PACK in 1 CARTON (11523-4331-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Sep 6, 2019
11523-4331-6	11523433106	8 BLISTER PACK in 1 CARTON (11523-4331-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Aug 23, 2006

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
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 5 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Bayer HealthCare LLC.
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021891
Marketing start: Aug 23, 2006
Listing expires: Dec 31, 2026
Identifiers: Product ID 11523-4331_453703bf-d4b7-d090-e063-6394a90a7ebfSPL ID 453703bf-d4b7-d090-e063-6394a90a7ebfSPL set ID 37732ca2-b454-4215-91a2-c62e0f7a56afRxCUI 665078, 668469UNII 7AJO3BO7QNUPC 0041100810748

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

N411523433101 followed by a unit qualifier and the quantity

Package 11523-4331-01. 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 Dec 5, 2025.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021891

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021891
Product	Strength	Form · route	Labeler	Product NDC
Claritinloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	11523-4328
Claritinloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	11523-4330
Claritin Chewable Cool Mint Flavorloratadine	Loratadine 10 mg/1	Tablet, ChewableOral	Bayer HealthCare LLC.	11523-4364
Claritin Chewable Grape and Bubblegumloratadine	—	KitOral	Bayer HealthCare LLC.	11523-0123