NDC codes

FDA NDC Directory
Product NDC (as listed)11523-0123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11523-0123Add 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
11523-0123-111523012301115230123011 KIT in 1 CARTON (11523-0123-1)Marketed from Sep 1, 2023

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

Generic name (nonproprietary)
loratadine
Dosage form
Kit
Route
Oral
Labeler
Bayer HealthCare LLC.NDC labeler code 11523
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021891
Marketing start
Listing expires
Identifiers
Product ID 11523-0123_4526df19-7a6e-0f19-e063-6394a90a3954SPL ID 4526df19-7a6e-0f19-e063-6394a90a3954SPL set ID 0371368b-dca6-af2f-e063-6394a90a0ac0RxCUI 665078, 668469UPC 0000000000000

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

N411523012301 followed by a unit qualifier and the quantity

Package 11523-0123-01. 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: ●runny nose ●itchy, watery eyes ●sneezing ●itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11523-0123

What is NDC 11523-0123?
11523-0123 is the product NDC for Claritin Chewable Grape and Bubblegum kit, listed with the FDA by Bayer HealthCare LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Claritin Chewable Grape and Bubblegum (Loratadine).
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 Chewable Grape and Bubblegum?
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.

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
ProductStrengthForm · routeLabelerProduct NDC
ClaritinloratadineLoratadine 5 mg/1Tablet, ChewableOralBayer HealthCare LLC.11523-4328
ClaritinloratadineLoratadine 5 mg/1Tablet, ChewableOralBayer HealthCare LLC.11523-4330
ClaritinloratadineLoratadine 5 mg/1Tablet, ChewableOralBayer HealthCare LLC.11523-4331
Claritin Chewable Cool Mint FlavorloratadineLoratadine 10 mg/1Tablet, ChewableOralBayer HealthCare LLC.11523-4364

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