What is NDC 71610-423?

71610-423 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?

108 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 71610-423 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-423Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0423Add 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
71610-423-60	71610042360	90 TABLET in 1 BOTTLE (71610-423-60)Marketed from May 1, 2020

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): Loratadine
Generic name (nonproprietary): loratadine
Active ingredients: Loratadine — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
Marketing start: Dec 6, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 71610-423_c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2SPL ID c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2SPL set ID 8ffe2faf-3253-4121-a069-6f46e319c6f0RxCUI 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

N471610042360 followed by a unit qualifier and the quantity

Package 71610-0423-60. 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 13, 2020.

Indications (excerpt from the label)

Uses 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 71610-423

What is NDC 71610-423?: 71610-423 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?: 108 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 109 Loratadine NDCs

Other NDCs under ANDA 076301

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

FDA NDC Directory listings under ANDA 076301
Product	Strength	Form · route	Labeler	Product NDC
Loratadine	Loratadine 10 mg/1	TabletOral	Major Pharmaceuticals	0904-6852
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8217
Berkley and Jensen Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	BJWC	68391-314
up and up allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Target Corporation	11673-612
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	Padagis Israel Pharmaceuticals Ltd	45802-650
Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Kroger Company	30142-612
allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Meijer Distribution Inc	41250-612
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	Proficient Rx LP	63187-601
members mark allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Sam's West Inc	68196-711
Loratadine antihistamineloratadine	Loratadine 10 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	66267-653
good neighbor pharmacy loratadineloratadine	Loratadine 10 mg/1	TabletOral	Amerisource Bergen	24385-471
good sense allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	L. Perrigo Company	0113-0612
foster and thrive allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Strategic Sourcing Services LLC	70677-1022
basic care allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Amazon.com Services LLC	72288-612
goodnow allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Gobrands, Inc	82501-0612
good sense allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7048
good sense allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7049
good sense allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7051
CareOne Allergy Relief 24 Hourloratadine	Loratadine 10 mg/1	TabletOral	American Sales Company	41520-612
equate allergy reliefloratadine	Loratadine 10 mg/1	TabletOral	Wal-Mart Stores Inc	49035-612

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