What is NDC 54838-554?

54838-554 is the product NDC for Loratadine, Loratadine 5 mg/5mL solution, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 54838. 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 54838-554 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54838-554Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54838-0554Add 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
54838-554-40	5483805544054838055440	120 mL in 1 CARTON (54838-554-40)Marketed from Nov 24, 2010

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/5mL
Dosage form: Solution
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 54838
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077421
Marketing start: Nov 24, 2010
Listing expires: Dec 31, 2026
Identifiers: Product ID 54838-554_fd40a94c-2173-4b80-a049-ab3c4faf24f4SPL ID fd40a94c-2173-4b80-a049-ab3c4faf24f4SPL set ID 069c4e75-1f9f-4ab5-9570-3d93d12c2a23RxCUI 692783UNII 7AJO3BO7QNUPC 0354838552409

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

N454838055440 followed by a unit qualifier and the quantity

Package 54838-0554-40. 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 19, 2025.

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 54838-554

What is NDC 54838-554?: 54838-554 is the product NDC for Loratadine, Loratadine 5 mg/5mL solution, listed with the FDA by Lannett Company, 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?: Lannett Company, Inc., NDC labeler code 54838. 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 077421

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

FDA NDC Directory listings under ANDA 077421
Product	Strength	Form · route	Labeler	Product NDC
Loratadine	Loratadine 5 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0557
Loratadine	Loratadine 5 mg/5mL	SolutionOral	A-S Medication Solutions	50090-1454
Loratadine	Loratadine 5 mg/5mL	SolutionOral	Lannett Company, Inc.	54838-558
Loratadine	Loratadine 5 mg/5mL	SolutionOral	NuCare Pharmaceuticals,Inc.	68071-4451