Loratadine (loratadine oral) NDC 58602-423

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-423Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0423Add 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
58602-423-11	58602042311	1 BOTTLE in 1 CARTON (58602-423-11) / 60 mL in 1 BOTTLEMarketed from Jun 29, 2018
58602-423-24	58602042324	1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLEMarketed from Jun 29, 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 oral
Active ingredients: Loratadine — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Aurohealth LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208931
Marketing start: Jun 29, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 58602-423_78515214-94d8-4977-aff5-8b9beb60042eSPL ID 78515214-94d8-4977-aff5-8b9beb60042eSPL set ID 0b86a9fe-db7e-470a-a8fa-d7d4373116baRxCUI 692783UNII 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

N458602042311 followed by a unit qualifier and the quantity

Package 58602-0423-11. 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 Jan 20, 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 208931

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

FDA NDC Directory listings under ANDA 208931
Product	Strength	Form · route	Labeler	Product NDC
Loratadineloratadine oral	Loratadine 5 mg/5mL	SolutionOral	KROGER COMPANY	30142-062
Loratadineloratadine oral	Loratadine 5 mg/5mL	SolutionOral	BluePoint Laboratories	68001-449
Loratadineloratadine oral	Loratadine 5 mg/5mL	SolutionOral	Better Living Brands LLC	21130-042