Loratadine NDC 54838-558

NDC codes

FDA NDC Directory

Product NDC (as listed)54838-558Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54838-0558Add 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
54838-558-40	54838055840	120 mL in 1 CARTON (54838-558-40)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.
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 54838-558_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

N454838055840 followed by a unit qualifier and the quantity

Package 54838-0558-40. 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)

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	NuCare Pharmaceuticals,Inc.	68071-4451
Loratadine	Loratadine 5 mg/5mL	SolutionOral	Lannett Company, Inc.	54838-554
Loratadine	Loratadine 5 mg/5mL	SolutionOral	A-S Medication Solutions	50090-1454