NDC codes

FDA NDC Directory
Product NDC (as listed)11523-4364Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11523-4364Add 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
11523-4364-111523436401115234364013 BLISTER PACK in 1 CARTON (11523-4364-1) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019
11523-4364-211523436402115234364021 BLISTER PACK in 1 CARTON (11523-4364-2) / 2 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019
11523-4364-311523436403115234364031 BLISTER PACK in 1 CARTON (11523-4364-3) / 4 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 · Sample package
11523-4364-411523436404115234364047 BLISTER PACK in 1 CARTON (11523-4364-4) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019
11523-4364-511523436405115234364058 BLISTER PACK in 1 CARTON (11523-4364-5) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019
11523-4364-611523436406115234364061 BLISTER PACK in 1 CARTON (11523-4364-6) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019
11523-4364-711523436407115234364071 BLISTER PACK in 1 POUCH (11523-4364-7) / 2 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019

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 Chewable Cool Mint FlavorSuffix: Cool Mint Flavor
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet, Chewable
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 11523-4364_453711b1-0b16-f203-e063-6394a90a34e1SPL ID 453711b1-0b16-f203-e063-6394a90a34e1SPL set ID 98b99bb9-d499-9ab4-e053-2a95a90a6ae6RxCUI 2265266, 2265267UNII 7AJO3BO7QN

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

N411523436401 followed by a unit qualifier and the quantity

Package 11523-4364-01. 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 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 11523-4364

What is NDC 11523-4364?
11523-4364 is the product NDC for Claritin Chewable Cool Mint Flavor, Loratadine 10 mg/1 tablet, chewable, 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?
Claritin Chewable Cool Mint Flavor (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 Chewable Cool Mint Flavor?
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 Grape and Bubblegumloratadine—KitOralBayer HealthCare LLC.11523-0123

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