What is NDC 25000-092?

25000-092 is the product NDC for Loratadine 10mg, Loratadine 10 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 4 package NDCs, shown above in 10- and 11-digit form.

MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 25000-092 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)25000-092Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25000-0092Add 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
25000-092-03	25000009203	1 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLEMarketed from Nov 21, 2024
25000-092-79	25000009279	1 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLEMarketed from Nov 21, 2024
25000-092-80	25000009280	365 TABLET in 1 BOTTLE (25000-092-80)Marketed from Nov 21, 2024
25000-092-81	25000009281	2 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACKMarketed from Nov 21, 2024

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: MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219223
Marketing start: Nov 21, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629SPL ID aa667b5f-a4ac-4129-bae9-f9c1de776629SPL set ID 3360d02d-612d-4cc5-acc9-2cc93713c387RxCUI 311372UNII 7AJO3BO7QNUPC 0325000092795, 0325000092801, 0325000092818, 0325000092030

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

N425000009203 followed by a unit qualifier and the quantity

Package 25000-0092-03. 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 25, 2024.

Indications (excerpt from the label)

USE(S) 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 25000-092

What is NDC 25000-092?: 25000-092 is the product NDC for Loratadine 10mg, Loratadine 10 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 4 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?: MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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	Allegiant Health	69168-475	69168-0475-0269168-0475-0569168-0475-08+5 more
Loratadine 10mg	Loratadine 10 mg/1	TabletOral	Meijer	79481-7870	79481-7870-03

Other NDCs under ANDA 219223

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

FDA NDC Directory listings under ANDA 219223
Product	Strength	Form · route	Labeler	Product NDC
Loratadine 10 mgloratadine tablets usp, 10 mg	Loratadine 10 mg/1	TabletOral	TIME CAP LABORATORIES, INC.	49483-732