What is NDC 63548-0753?

63548-0753 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by PLD Acquisitions LLC DBA Avma Pharma Solutions. It has 3 package NDCs, shown above in 10- and 11-digit form.

PLD Acquisitions LLC DBA Avma Pharma Solutions, NDC labeler code 63548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Loratadine?

109 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loratadine NDC 63548-0753 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63548-0753Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63548-0753Add 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
63548-0753-0	6354807530063548075300	300 TABLET in 1 BOTTLE, PLASTIC (63548-0753-0)Marketed from Oct 30, 2018
63548-0753-1	6354807530163548075301	100 TABLET in 1 BOTTLE, PLASTIC (63548-0753-1)Marketed from Oct 30, 2018
63548-0753-3	6354807530363548075303	30 TABLET in 1 BOTTLE, PLASTIC (63548-0753-3)Marketed from Oct 30, 2018

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): Loratadine
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: PLD Acquisitions LLC DBA Avma Pharma SolutionsNDC labeler code 63548
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075209
Marketing start: Oct 30, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 63548-0753_c24222bc-72ef-4c15-b7c2-9401fe5f40a6SPL ID c24222bc-72ef-4c15-b7c2-9401fe5f40a6SPL set ID 2edb53f8-7661-4e54-bb50-e03078bae3bfRxCUI 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

N463548075300 followed by a unit qualifier and the quantity

Package 63548-0753-00. 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 May 4, 2023.

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.

Full label on DailyMed (opens in a new tab)

About NDC 63548-0753

What is NDC 63548-0753?: 63548-0753 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by PLD Acquisitions LLC DBA Avma Pharma Solutions. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loratadine.
What is the active ingredient?: Loratadine.
Who is the labeler?: PLD Acquisitions LLC DBA Avma Pharma Solutions, NDC labeler code 63548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Loratadine?: 109 other product NDCs are listed under this name. See all Loratadine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Loratadine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loratadine	Loratadine 10 mg/1	TabletOral	YYBA CORP	73581-229	73581-0229-0173581-0229-03
Loratadine	Loratadine 10 mg/1	TabletOral	AvPAK	50268-777	50268-0777-01
Loratadine	Loratadine 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4103	68788-4103-0068788-4103-0168788-4103-03+2 more
Loratadine	Loratadine 10 mg/1	TabletOral	Safecor Health, LLC	48433-064	48433-0064-20
Loratadine	Loratadine 10 mg/1	TabletOral	Aurobindo Pharma Limited	84386-119	84386-0119-78
Loratadine	Loratadine 10 mg/1	TabletOral	Cabinet Health P.B.C.	82725-0142	82725-0142-0182725-0142-0282725-0142-03+1 more
Loratadine	Loratadine 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0188	55154-0188-00
Loratadine	Loratadine 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7511	00904-7511-61
Loratadine	Loratadine 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8659	68788-8659-0068788-8659-0168788-8659-03+2 more
Loratadine	Loratadine 10 mg/1	Tablet, Orally disintegratingOral	Tenshi Kaizen Pvt Ltd	72983-503	72983-0503-06

All 110 Loratadine NDCs

Other NDCs under ANDA 075209

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

FDA NDC Directory listings under ANDA 075209
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	Loratadine 10 mg/1	TabletOral	Bayer HealthCare LLC.	11523-0800
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

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