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 | 11523080001 | 1 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACKMarketed from Mar 16, 2022 | |
| 11523-0800-2 | 11523080002 | 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.
- 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.
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 |
|---|---|---|---|---|
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-658 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2181 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0007 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Select Consumer Group | 85237-1630 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-938 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4016 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-350 |
| Indoor Outdoor Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-0858 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-718 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2392 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-985 |
| CounterAct Allergyloratadine | Loratadine 10 mg/1 | TabletOral | Melaleuca, Inc. | 54473-166 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6164 |
| 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 | WALMART INC. (see also Equate) | 79903-156 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-146 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-150 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-147 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Safeway, Inc. | 21130-914 |
| Claritinloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-9742 |
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