Over-the-counter drug · NDA
Claritin (Loratadine) NDC 11523-4331
Loratadine 5 mg/1 · Tablet, Chewable · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-4331-1 | 1152343310111523433101 | 4 BLISTER PACK in 1 CARTON (11523-4331-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Aug 23, 2006 | |
| 11523-4331-2 | 1152343310211523433102 | 6 BLISTER PACK in 1 CARTON (11523-4331-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Sep 6, 2019 | |
| 11523-4331-6 | 1152343310611523433106 | 8 BLISTER PACK in 1 CARTON (11523-4331-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Aug 23, 2006 |
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
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 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 11523-4331_453703bf-d4b7-d090-e063-6394a90a7ebfSPL ID 453703bf-d4b7-d090-e063-6394a90a7ebfSPL set ID 37732ca2-b454-4215-91a2-c62e0f7a56afRxCUI 665078, 668469UNII 7AJO3BO7QNUPC 0041100810748
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
N411523433101followed by a unit qualifier and the quantityPackage 11523-4331-01. 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 11523-4331
- What is NDC 11523-4331?
- 11523-4331 is the product NDC for Claritin (loratadine), Loratadine 5 mg/1 tablet, chewable, listed with the FDA by Bayer HealthCare LLC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Claritin (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?
- 14 other product NDCs are listed under this name. See all Claritin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Claritin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Claritinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-0104 | 11523-0104-0111523-0104-0211523-0104-03+3 more |
| Claritinloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-9742 | 66715-9742-0166715-9742-02 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | R J General Corporation | 70264-030 | 70264-0030-01 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0007 | 11523-0007-0111523-0007-0211523-0007-03+6 more |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0800 | 11523-0800-0111523-0800-02 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Select Consumer Group | 85237-1630 | 85237-1630-0185237-1630-0385237-1630-04 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Navajo Manufacturing Company | 67751-153 | — |
| Claritinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-4330 | 11523-4330-0111523-4330-0311523-4330-04 |
| Claritinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-4328 | 11523-4328-0111523-4328-0211523-4328-03+5 more |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-1527 | 11523-1527-0111523-1527-02 |
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 |
| Claritin Chewable Cool Mint Flavorloratadine | Loratadine 10 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-4364 |
| Claritin Chewable Grape and Bubblegumloratadine | — | KitOral | Bayer HealthCare LLC. | 11523-0123 |