NDC codes

FDA NDC Directory
Product NDC (as listed)11523-4360Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11523-4360Add 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
11523-4360-1115234360011 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLEMarketed from May 26, 2015
11523-4360-2115234360021 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLEMarketed from Sep 25, 2015
11523-4360-3115234360031 BOTTLE in 1 CARTON (11523-4360-3) / 150 mL in 1 BOTTLEMarketed from Jan 1, 2016
11523-4360-4115234360041 BOTTLE in 1 CARTON (11523-4360-4) / 30 mL in 1 BOTTLEMarketed from Nov 1, 2015
11523-4360-5115234360051 BOTTLE in 1 CARTON (11523-4360-5) / 240 mL in 1 BOTTLEMarketed from May 26, 2015
11523-4360-6115234360061 BOTTLE in 1 CARTON (11523-4360-6) / 180 mL in 1 BOTTLEMarketed from Oct 5, 2015
11523-4360-7115234360072 BOTTLE in 1 CARTON (11523-4360-7) / 180 mL in 1 BOTTLEMarketed from Mar 1, 2016

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)
Children Claritin AllergySuffix: Allergy
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 5 mg/5mL
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 11523-4360_352ebcfd-07bb-a60e-e063-6394a90a5d70SPL ID 352ebcfd-07bb-a60e-e063-6394a90a5d70SPL set ID 170061e9-e529-4ff0-e054-00144ff8d46cRxCUI 692783, 755476UNII 7AJO3BO7QNUPC 0041100810991

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

N411523436001 followed by a unit qualifier and the quantity

Package 11523-4360-01. 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 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)

About NDC 11523-4360

What is NDC 11523-4360?
11523-4360 is the product NDC for Children Claritin Allergy (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Bayer HealthCare LLC.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Children 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 Children 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
Claritin AllergyloratadineLoratadine 1 mg/mLSolutionOralBayer HealthCare LLC.11523-0101

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