Over-the-counter drug · NDA
Claritin Chewable Cool Mint Flavor NDC 11523-4364
loratadine · Loratadine 10 mg/1 · Tablet, Chewable · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-4364-1 | 11523436401 | 3 BLISTER PACK in 1 CARTON (11523-4364-1) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 | |
| 11523-4364-2 | 11523436402 | 1 BLISTER PACK in 1 CARTON (11523-4364-2) / 2 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 | |
| 11523-4364-3 | 11523436403 | 1 BLISTER PACK in 1 CARTON (11523-4364-3) / 4 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 · Sample package | |
| 11523-4364-4 | 11523436404 | 7 BLISTER PACK in 1 CARTON (11523-4364-4) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 | |
| 11523-4364-5 | 11523436405 | 8 BLISTER PACK in 1 CARTON (11523-4364-5) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 | |
| 11523-4364-6 | 11523436406 | 1 BLISTER PACK in 1 CARTON (11523-4364-6) / 8 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Dec 9, 2019 | |
| 11523-4364-7 | 11523436407 | 1 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.
- 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
N411523436401followed by a unit qualifier and the quantityPackage 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.
Other NDCs under NDA 021891
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |
| Claritinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-4331 |
| Claritin Chewable Grape and Bubblegumloratadine | — | KitOral | Bayer HealthCare LLC. | 11523-0123 |