Over-the-counter drug · ANDA
Claritin (Loratadine) NDC 11523-0104
Loratadine 5 mg/1 · Tablet, Chewable · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-0104-1 | 1152301040111523010401 | 1 BLISTER PACK in 1 CARTON (11523-0104-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Feb 8, 2023 | |
| 11523-0104-2 | 1152301040211523010402 | 2 BLISTER PACK in 1 CARTON (11523-0104-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Feb 8, 2023 | |
| 11523-0104-3 | 1152301040311523010403 | 3 BLISTER PACK in 1 CARTON (11523-0104-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Feb 8, 2023 | |
| 11523-0104-4 | 1152301040411523010404 | 4 BLISTER PACK in 1 CARTON (11523-0104-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Feb 8, 2023 | |
| 11523-0104-5 | 1152301040511523010405 | 6 BLISTER PACK in 1 CARTON (11523-0104-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Feb 8, 2023 | |
| 11523-0104-6 | 1152301040611523010406 | 8 BLISTER PACK in 1 CARTON (11523-0104-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Feb 5, 2023 |
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
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210033
- Marketing start
- Listing expires
- Identifiers
- Product ID 11523-0104_4526d753-7999-0ec3-e063-6294a90a270fSPL ID 4526d753-7999-0ec3-e063-6294a90a270fSPL set ID f3b9c643-a605-7702-e053-2995a90a6130RxCUI 665078, 668469UNII 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
N411523010401followed by a unit qualifier and the quantityPackage 11523-0104-01. 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 11523-0104
- What is NDC 11523-0104?
- 11523-0104 is the product NDC for Claritin (loratadine), Loratadine 5 mg/1 tablet, chewable, listed with the FDA by Bayer HealthCare LLC.. It has 6 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 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 5 mg/1 | Tablet, ChewableOral | Bayer HealthCare LLC. | 11523-4331 | 11523-4331-0111523-4331-0211523-4331-06 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-1527 | 11523-1527-0111523-1527-02 |
Other NDCs under ANDA 210033
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 |
|---|---|---|---|---|
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Meijer Distribution Inc | 41250-629 |
| good sense childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | L. Perrigo Company | 0113-1019 |
| careone childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | American Sales Company | 41520-716 |
| dg health childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Dolgencorp, LLC | 55910-807 |
| Basic Care Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-901 |
| Berkley and Jensen Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | BJWC | 68391-301 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | H E B | 37808-506 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Amazon.com Services LLC | 72288-929 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-133 |
| Equaline Childrens Allergy Reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | United Natural Foods, Inc. dba UNFI | 41163-364 |
| foster and thrive childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Strategic Sourcing Services LLC | 70677-1043 |
| childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Rite Aid Corporation | 11822-0801 |
| topcare childrens allergy reliefloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Topco Associates LLC | 36800-363 |