What is NDC 68016-526?

68016-526 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Premier Value. It has 4 package NDCs, shown above in 10- and 11-digit form.

Premier Value, NDC labeler code 68016. 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?

107 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 68016-526 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-526Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0526Add 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
68016-526-31	6801605263168016052631	30 TABLET in 1 BLISTER PACK (68016-526-31)Marketed from Aug 19, 2003
68016-526-60	6801605266068016052660	60 TABLET in 1 BOTTLE (68016-526-60)Marketed from Aug 19, 2003
68016-526-69	6801605266968016052669	10 TABLET in 1 BLISTER PACK (68016-526-69)Marketed from Aug 19, 2003
68016-526-90	6801605269068016052690	90 TABLET in 1 BOTTLE (68016-526-90)Marketed from Aug 19, 2003

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: Premier ValueNDC labeler code 68016
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076134
Marketing start: Aug 19, 2003
Listing expires: Dec 31, 2026
Identifiers: Product ID 68016-526_78c14cff-325e-4106-a9a4-cb5281ceec58SPL ID 78c14cff-325e-4106-a9a4-cb5281ceec58SPL set ID 778a6979-ea47-4381-8c40-84b3c2325a7eRxCUI 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

N468016052631 followed by a unit qualifier and the quantity

Package 68016-0526-31. 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 Jan 11, 2018.

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 68016-526

What is NDC 68016-526?: 68016-526 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Premier Value. It has 4 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?: Premier Value, NDC labeler code 68016. 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?: 107 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 108 Loratadine NDCs

Other NDCs under ANDA 076134

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

FDA NDC Directory listings under ANDA 076134
Product	Strength	Form · route	Labeler	Product NDC
Green Guard 24 Hour Allergy Reliefloratadine	Loratadine 10 mg/1	Tablet, Film coatedOral	Unifirst First Aid Corporation	47682-118
Handy Solutions 24 Hour Allergyloratadine	Loratadine 10 mg/1	Tablet, Film coatedOral	Navajo Manufacturing Company Inc.	67751-163
Loratadine	Loratadine 10 mg/1	TabletOral	SAFEWAY INC.	21130-526
Loratadine	Loratadine 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-4976
Loratadine	Loratadine 10 mg/1	TabletOral	CVS Pharmacy	59779-528
Loratadine	Loratadine 10 mg/1	TabletOral	Chain Drug Marketing Association Inc.	63868-151
Loratadine	Loratadine 10 mg/1	TabletOral	Valu Merchandisers Company	63941-526
Loratadine	Loratadine 10 mg/1	TabletOral	American Health Packaging	68084-248
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-763
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	HEB	37808-529
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-2387
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7507
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7508
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	DISCOUNT DRUG MART	53943-975
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	55289-728
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Proficient Rx LP	63187-100
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Bryant Ranch Prepack	63629-7772
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	WinCo Foods, LLC	67091-245
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	WinCo Foods, LLC	67091-246
Loratadine Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	LIDL US, LLC	71141-132

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