Over-the-counter drug · ANDA
Claritin (Loratadine) NDC 11523-0800
Loratadine 10 mg/1 · Tablet · Oral · Bayer HealthCare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-0800-1 | 1152308000111523080001 | 1 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACKMarketed from Mar 16, 2022 | |
| 11523-0800-2 | 1152308000211523080002 | 100 TABLET in 1 BOTTLE (11523-0800-2)Marketed from Mar 16, 2022 |
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 — 10 mg/1
- Dosage form
- Tablet
- 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 075209
- Marketing start
- Listing expires
- Identifiers
- Product ID 11523-0800_4526e2eb-ee8d-3ac4-e063-6394a90a133fSPL ID 4526e2eb-ee8d-3ac4-e063-6394a90a133fSPL set ID dc65f7ec-bb83-7b29-e053-2995a90a99deRxCUI 206805, 311372UNII 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
N411523080001followed by a unit qualifier and the quantityPackage 11523-0800-01. 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 11523-0800
- What is NDC 11523-0800?
- 11523-0800 is the product NDC for Claritin (loratadine), Loratadine 10 mg/1 tablet, 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 (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 | 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 075209
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 |
|---|---|---|---|---|
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Safeway, Inc. | 21130-914 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-938 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-718 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-985 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-156 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-437 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-146 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-147 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6164 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-658 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-350 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4016 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2181 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-150 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0007 |
| Claritinloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-9742 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Select Consumer Group | 85237-1630 |
| CounterAct Allergyloratadine | Loratadine 10 mg/1 | TabletOral | Melaleuca, Inc. | 54473-166 |
| Indoor Outdoor Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-0858 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0753 |
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