What is NDC 63654-415?

63654-415 is the product NDC for XL - 3 Allergy, Loratadine 10 mg/1 tablet, listed with the FDA by Selder, S.A. de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.

Selder, S.A. de C.V., NDC labeler code 63654. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for XL - 3 Allergy?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

XL - 3 Allergy NDC 63654-415 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63654-415Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63654-0415Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63654-415-10	6365404151063654041510	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.NDC labeler code 63654
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
Marketing start: Apr 10, 2024
Listing expires: Dec 31, 2026
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

N463654041510 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Apr 10, 2024.

Indications (excerpt from the label)

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63654-415

What is NDC 63654-415?: 63654-415 is the product NDC for XL - 3 Allergy, Loratadine 10 mg/1 tablet, listed with the FDA by Selder, S.A. de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: XL - 3 Allergy.
What is the active ingredient?: Loratadine.
Who is the labeler?: Selder, S.A. de C.V., NDC labeler code 63654. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for XL - 3 Allergy?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 210722

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210722
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Grocery Outlet, Inc	85828-193
Loratadine	Loratadine 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2529
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	AAA PHARMACEUTICAL, INC.	57344-193
Green Guard 24 Hour Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Unifirst First Aid Corporation	47682-117
Loratadine	Loratadine 10 mg/1	TabletOral	Bi-Mart	37835-621
Loratadine	Loratadine 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3596
McKesson Loradatineloratainde	Loratadine 10 mg/1	TabletOral	McKesson Medical Surgical	68599-4785
Loratadine	Loratadine 10 mg/1	TabletOral	Safeway, Inc	21130-780
Loratadine	Loratadine 10 mg/1	TabletOral	Advanced Rx LLC	80513-711
Loratadine	Loratadine 10 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-162
ValuMeds Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Cabinet Health P.B.C.	82725-1042
Loratadine	Loratadine 10 mg/1	TabletOral	Spirit Pharmaceuticals LLC	68210-4110
Loratadine	Loratadine 10 mg/1	TabletOral	Granules India Limited	62207-787
LORATADINE ALLERGY RELIEF 10mgloratadine	Loratadine 10 mg/1	TabletOral	YYBA CORP	73581-230
Medique Loradamedloratadine	Loratadine 10 mg/1	TabletOral	Unifirst First Aid Corporation	47682-403
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Dr. Reddy's Laboratories Inc.	75907-434
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Allegiant Health	69168-414
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Valu Merchandisers Company	63941-193
Loratadine	Loratadine 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-831
Non-Drowsy Allergy Relief, 24-7 Lifeloratadine tablet	Loratadine 10 mg/1	TabletOral	Lil' Drug Store Products, Inc.	66715-6551

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