Over-the-counter drug · NDA
Claritin Reditabs (Loratadine) NDC 11523-4329
Loratadine 10 mg/1 · Tablet, Orally disintegrating · Oral · Bayer Healthcare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-4329-1 | 1152343290111523432901 | 2 CARTON in 1 PACKAGE, COMBINATION (11523-4329-1) / 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 27, 2002 | |
| 11523-4329-2 | 1152343290211523432902 | 6 BLISTER PACK in 1 CARTON (11523-4329-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 27, 2002 |
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 ReditabsSuffix: Reditabs
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Bayer Healthcare LLC.NDC labeler code 11523
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020704
- Marketing start
- Listing expires
- Identifiers
- Product ID 11523-4329_4536fe84-5b46-ca4c-e063-6394a90ad03aSPL ID 4536fe84-5b46-ca4c-e063-6394a90ad03aSPL set ID b681ea25-d00b-4c8a-8054-cc6f983ce337RxCUI 311373, 744830UNII 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
N411523432901followed by a unit qualifier and the quantityPackage 11523-4329-01. 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.
About NDC 11523-4329
- What is NDC 11523-4329?
- 11523-4329 is the product NDC for Claritin Reditabs (loratadine), Loratadine 10 mg/1 tablet, orally disintegrating, listed with the FDA by Bayer Healthcare LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Claritin Reditabs (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 Reditabs?
- 2 other product NDCs are listed under this name. See all Claritin Reditabs NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Claritin Reditabs products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Claritin Reditabsloratadine | Loratadine 5 mg/1 | Tablet, Orally disintegratingOral | Bayer HealthCare LLC | 11523-7202 | 11523-7202-0111523-7202-03 |
| Claritin Reditabsloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Bayer Healthcare LLC. | 11523-7157 | 11523-7157-0211523-7157-0311523-7157-04+3 more |
Other NDCs under NDA 020704
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 Reditabsloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Bayer Healthcare LLC. | 11523-7157 |