Over-the-counter drug · ANDA
XL - 3 Allergy NDC 63654-415
Loratadine 10 mg/1 · Tablet · Oral · Selder, S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63654-415-10 | 63654041510 | 1 BLISTER PACK in 1 CARTON (63654-415-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 10, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- XL - 3 Allergy
- Generic name (nonproprietary)
- xl - 3 allergy
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Selder, S.A. de C.V.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
- Marketing start
- Listing expires
- Identifiers
- Product ID 63654-415_928e4434-6c15-4bf1-bcfd-1f56a17510edSPL ID 928e4434-6c15-4bf1-bcfd-1f56a17510edSPL set ID 059a6e72-888e-4cb3-8722-4c3acbd6b4b0RxCUI 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
N463654041510followed by a unit qualifier and the quantityPackage 63654-0415-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210722
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 |
|---|---|---|---|---|
| McKesson Loradatineloratainde | Loratadine 10 mg/1 | TabletOral | McKesson Medical Surgical | 68599-4785 |
| ValuMeds Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1042 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3596 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Spirit Pharmaceuticals LLC | 68210-4110 |
| First Aid Direct Allergy Reliefloratadine tablets | Loratadine 10 mg/1 | TabletOral | Cintas Corporation | 42961-120 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Advanced Rx LLC | 80513-711 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-162 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Granules India Limited | 62207-787 |
| Green Guard 24 Hour Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-117 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2431 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-9787 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Allegiant Health | 69168-414 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AMZ789 LLC | 73629-003 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bi-Mart | 37835-621 |
| Curist Allergy Reliefloratadine 10 mg | Loratadine 10 mg/1 | TabletOral | Little Pharma, Inc. | 72559-033 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HARRIS TEETER | 72036-193 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-831 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Valu Merchandisers Company | 63941-193 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | FSA STORE INC. | 81522-393 |
| Non-Drowsy Allergy Relief, 24-7 Lifeloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-6551 |
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