What is NDC 0378-8880?

0378-8880 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-8880 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8880Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8880Add 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
0378-8880-10	00378888010	1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)Marketed from Jun 1, 2011

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076154
Marketing start: Jun 1, 2011
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-8880_1392dd15-842c-4689-87ba-caafc0503bcaSPL ID 1392dd15-842c-4689-87ba-caafc0503bcaSPL set ID 3b307aea-5a68-4c82-959a-cda4ffbd0a4aRxCUI 311372UNII 7AJO3BO7QNUPC 0303788880100

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

N400378888010 followed by a unit qualifier and the quantity

Package 00378-8880-10. 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 Nov 15, 2013.

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 0378-8880

What is NDC 0378-8880?: 0378-8880 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 076154

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

FDA NDC Directory listings under ANDA 076154
Product	Strength	Form · route	Labeler	Product NDC
Loratadine	Loratadine 10 mg/1	TabletOral	Safecor Health, LLC	48433-064
Loratadine	Loratadine 10 mg/1	TabletOral	Mylan Institutional Inc.	51079-246