NDC codes

FDA NDC Directory
Product NDC (as listed)11523-0101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11523-0101Add 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
11523-0101-1115230101011 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLEMarketed from Jun 28, 2024
11523-0101-2115230101021 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLEMarketed from Jun 28, 2024
11523-0101-3115230101031 BOTTLE in 1 CARTON (11523-0101-3) / 240 mL in 1 BOTTLEMarketed from Jun 28, 2024

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 AllergySuffix: Allergy
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 1 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Bayer HealthCare LLC.NDC labeler code 11523
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020641
Marketing start
Listing expires
Identifiers
Product ID 11523-0101_4526da60-c33b-fb4a-e063-6294a90a8692SPL ID 4526da60-c33b-fb4a-e063-6294a90a8692SPL set ID 19afd658-8c67-af44-e063-6394a90abadaRxCUI 692783, 755476UNII 7AJO3BO7QNUPC 0041100595416

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

N411523010101 followed by a unit qualifier and the quantity

Package 11523-0101-01. 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 11523-0101

What is NDC 11523-0101?
11523-0101 is the product NDC for Claritin Allergy (loratadine), Loratadine 1 mg/mL solution, 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 Allergy (Loratadine).
What is the active ingredient?
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 Allergy?
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 020641

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

FDA NDC Directory listings under NDA 020641
ProductStrengthForm · routeLabelerProduct NDC
Children Claritin AllergyloratadineLoratadine 5 mg/5mLSolutionOralBayer HealthCare LLC.11523-4360

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