What is NDC 68016-053?

68016-053 is the product NDC for Loratadine, Loratadine 5 mg/1 tablet, listed with the FDA by Premier Value. It has 2 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?

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 68016-053 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68016-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68016-0053Add 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
68016-053-10	6801600531068016005310	1 BLISTER PACK in 1 CARTON (68016-053-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2018
68016-053-30	6801600533068016005330	1 BLISTER PACK in 1 CARTON (68016-053-30) / 30 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2018

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 — 5 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 210088
Marketing start: Apr 1, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 68016-053_2a409885-2a3e-34d8-e063-6394a90aa4d9SPL ID 2a409885-2a3e-34d8-e063-6394a90aa4d9SPL set ID dc22862e-fe91-4900-8c2b-1ca45aeedbf0RxCUI 665078UNII 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

N468016005310 followed by a unit qualifier and the quantity

Package 68016-0053-10. 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 Dec 27, 2024.

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 68016-053

What is NDC 68016-053?: 68016-053 is the product NDC for Loratadine, Loratadine 5 mg/1 tablet, listed with the FDA by Premier Value. It has 2 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?: 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 210088

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

FDA NDC Directory listings under ANDA 210088
Product	Strength	Form · route	Labeler	Product NDC
Loratadine	Loratadine 5 mg/1	Tablet, ChewableOral	Wal-Mart Stores, Inc	49035-953
Wal-itinloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	WALGREENS CO.	0363-9995
Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	SAFEWAY	21130-999
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	UP & UP	11673-111
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	UP & UP	11673-115
Curist Childrens Allergy Reliefloratadine 5 mg chewable tablets	Loratadine 5 mg/1	Tablet, ChewableOral	Little Pharma, Inc.	72559-031
Loratadine	Loratadine 5 mg/1	Tablet, ChewableOral	WALGREEN COMPANY	0363-0752
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	SAFEWAY	21130-646
Wal-itinloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	Walgreens	0363-0754
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	PUBLIX SUPER MARKETS, INC	56062-900
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	PUBLIX SUPER MARKETS, INC	56062-921
Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	TARGET CORPORATION	11673-310
Loratadine	Loratadine 5 mg/1	Tablet, ChewableOral	PUBLIX SUPER MARKETS INC	56062-990
Loratadine	Loratadine 5 mg/1	Tablet, ChewableOral	KROGER COMPANY	30142-984
Loratadine	Loratadine 5 mg/1	Tablet, ChewableOral	KROGER COMPANY	30142-996
Loratadine	Loratadine 5 mg/1	Tablet, ChewableOral	Rite Aid	11822-7240
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	Ohm Laboratories Inc.	51660-112
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	CVS PHARMACY, INC	69842-894
Dye-Free Childrens Loratadineloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	CVS PHARMACY, INC	69842-895
Childrens Allergyloratadine	Loratadine 5 mg/1	Tablet, ChewableOral	TARGET CORPORATION	11673-996

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