Over-the-counter drug · NDA
Children Claritin Allergy (Loratadine) NDC 11523-4360
Loratadine 5 mg/5mL · Solution · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-4360-1 | 11523436001 | 1 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLEMarketed from May 26, 2015 | |
| 11523-4360-2 | 11523436002 | 1 BOTTLE in 1 CARTON (11523-4360-2) / 120 mL in 1 BOTTLEMarketed from Sep 25, 2015 | |
| 11523-4360-3 | 11523436003 | 1 BOTTLE in 1 CARTON (11523-4360-3) / 150 mL in 1 BOTTLEMarketed from Jan 1, 2016 | |
| 11523-4360-4 | 11523436004 | 1 BOTTLE in 1 CARTON (11523-4360-4) / 30 mL in 1 BOTTLEMarketed from Nov 1, 2015 | |
| 11523-4360-5 | 11523436005 | 1 BOTTLE in 1 CARTON (11523-4360-5) / 240 mL in 1 BOTTLEMarketed from May 26, 2015 | |
| 11523-4360-6 | 11523436006 | 1 BOTTLE in 1 CARTON (11523-4360-6) / 180 mL in 1 BOTTLEMarketed from Oct 5, 2015 | |
| 11523-4360-7 | 11523436007 | 2 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
N411523436001followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Claritin Allergyloratadine | Loratadine 1 mg/mL | SolutionOral | Bayer HealthCare LLC. | 11523-0101 |