What is NDC 69168-475?

69168-475 is the product NDC for Loratadine 10mg, Loratadine 10 mg/1 tablet, listed with the FDA by Allegiant Health. It has 8 package NDCs, shown above in 10- and 11-digit form.

Allegiant Health, NDC labeler code 69168. 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 10mg?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Loratadine 10mg NDC 69168-475 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69168-475Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69168-0475Add 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
69168-475-02	69168047502	150 TABLET in 1 BOTTLE (69168-475-02)Marketed from Mar 18, 2025
69168-475-05	69168047505	500 TABLET in 1 BOTTLE (69168-475-05)Marketed from Nov 11, 2025
69168-475-08	69168047508	1 BLISTER PACK in 1 CARTON (69168-475-08) / 5 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2025
69168-475-09	69168047509	1 BLISTER PACK in 1 CARTON (69168-475-09) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2025
69168-475-17	69168047517	300 TABLET in 1 BOTTLE (69168-475-17)Marketed from Sep 30, 2025
69168-475-30	69168047530	1 BOTTLE in 1 CARTON (69168-475-30) / 30 TABLET in 1 BOTTLEMarketed from Sep 30, 2025
69168-475-60	69168047560	60 TABLET in 1 BOTTLE (69168-475-60)Marketed from Sep 30, 2025
69168-475-99	69168047599	365 TABLET in 1 BOTTLE (69168-475-99)Marketed from Sep 30, 2025

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 10mg
Generic name (nonproprietary): loratadine 10mg
Active ingredients: Loratadine — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Allegiant HealthNDC labeler code 69168
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211718
Marketing start: Mar 18, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 69168-475_1307fce8-d753-4df5-90f0-a902befdfe35SPL ID 1307fce8-d753-4df5-90f0-a902befdfe35SPL set ID f0db3a13-43e6-4243-9a3a-7808ddd005e1RxCUI 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

N469168047502 followed by a unit qualifier and the quantity

Package 69168-0475-02. 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 16, 2020.

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 69168-475

What is NDC 69168-475?: 69168-475 is the product NDC for Loratadine 10mg, Loratadine 10 mg/1 tablet, listed with the FDA by Allegiant Health. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Loratadine 10mg.
What is the active ingredient?: Loratadine.
Who is the labeler?: Allegiant Health, NDC labeler code 69168. 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 10mg?: 3 other product NDCs are listed under this name. See all Loratadine 10mg 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 10mg NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Loratadine 10mgloratadine	Loratadine 10 mg/1	TabletOral	BETTER LIVING BRANDS, LLC	21130-932	21130-0932-65
Loratadine 10mg	Loratadine 10 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-092	25000-0092-0325000-0092-7925000-0092-80+1 more
Loratadine 10mg	Loratadine 10 mg/1	TabletOral	Meijer	79481-7870	79481-7870-03

Other NDCs under ANDA 211718

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

FDA NDC Directory listings under ANDA 211718
Product	Strength	Form · route	Labeler	Product NDC
Loratadine	Loratadine 10 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8605
Loratadine	Loratadine 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2551
Loratadine	Loratadine 10 mg/1	TabletOral	Camber Consumer Care Inc	69230-323
Loratadine	Loratadine 10 mg/1	TabletOral	AvPAK	50268-777
Loratadine	Loratadine 10 mg/1	TabletOral	Bryant Ranch Prepack	71335-2391