What is NDC 68001-438?

68001-438 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 4 package NDCs, shown above in 10- and 11-digit form.

BluePoint Laboratories, NDC labeler code 68001. 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 68001-438 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-438Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0438Add 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
68001-438-00	6800104380068001043800	1 BOTTLE in 1 CARTON (68001-438-00) / 100 TABLET in 1 BOTTLEMarketed from Aug 26, 2020
68001-438-04	6800104380468001043804	1 BOTTLE in 1 CARTON (68001-438-04) / 30 TABLET in 1 BOTTLEMarketed from Aug 26, 2020
68001-438-96	6800104389668001043896	10 BLISTER PACK in 1 CARTON (68001-438-96) / 10 TABLET in 1 BLISTER PACK (68001-438-16)Marketed from Aug 26, 2020
68001-438-97	6800104389768001043897	1 BOTTLE in 1 CARTON (68001-438-97) / 300 TABLET in 1 BOTTLEMarketed from Aug 26, 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: BluePoint LaboratoriesNDC labeler code 68001
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208314
Marketing start: Aug 26, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 68001-438_e1e021de-1501-2fe3-e053-2a95a90a7be9SPL ID e1e021de-1501-2fe3-e053-2a95a90a7be9SPL set ID adc506ed-7a7a-facc-e053-2a95a90ae147RxCUI 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

N468001043800 followed by a unit qualifier and the quantity

Package 68001-0438-00. 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 Jun 20, 2022.

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 68001-438

What is NDC 68001-438?: 68001-438 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by BluePoint Laboratories. 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?: BluePoint Laboratories, NDC labeler code 68001. 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 208314

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

FDA NDC Directory listings under ANDA 208314
Product	Strength	Form · route	Labeler	Product NDC
365 Whole Foods Market Loratadineloratadine	Loratadine 10 mg/1	TabletOral	Whole Foods Market, Inc.	42681-0053
ALLERGY RELIEF 10mgloratadine	Loratadine 10 mg/1	TabletOral	YYBA CORP	73581-203
Amazon Basic Care Allergy Reliefloratadine	Loratadine 10 mg/1	TabletOral	Amazon.com Services LLC	72288-452
CONTAC Allergyloratadine	Loratadine 10 mg/1	TabletOral	Vespyr Brands LLC	71179-010
Loratadine	Loratadine 10 mg/1	TabletOral	WALGREEN CO.	0363-9603
Loratadine	Loratadine 10 mg/1	TabletOral	Major Pharmaceuticals	0904-7426
Loratadine	Loratadine 10 mg/1	TabletOral	KROGER COMPANY	30142-066
Loratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7752
Loratadine	Loratadine 10 mg/1	TabletOral	A-S Medication Solutions	50090-7753
Loratadine	Loratadine 10 mg/1	TabletOral	McLane Company, Inc.	57243-200
Loratadine	Loratadine 10 mg/1	TabletOral	Aurohealth LLC	58602-702
Loratadine	Loratadine 10 mg/1	TabletOral	Aurohealth LLC	58602-831
Loratadine	Loratadine 10 mg/1	TabletOral	Aurohealth LLC	58602-847
Loratadine	Loratadine 10 mg/1	TabletOral	Winco Foods, LLC.	67091-408
Loratadine	Loratadine 10 mg/1	TabletOral	Chain Drug Consortium, LLC	68016-094
Loratadine	Loratadine 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4103
Loratadine	Loratadine 10 mg/1	TabletOral	CVS Pharmacy, Inc.	69842-242
Loratadine	Loratadine 10 mg/1	TabletOral	Cardinal Health	70000-0583
Loratadine	Loratadine 10 mg/1	TabletOral	YYBA CORP	73581-229
Loratadine	Loratadine 10 mg/1	TabletOral	Aurobindo Pharma Limited	84386-119