What is NDC 25000-021?

25000-021 is the product NDC for Loratadine, Loratadine 10 mg/1 capsule, liquid filled, listed with the FDA by MARKSANS PHARMA LIMITED. It has 6 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?

109 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 25000-021 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)25000-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25000-0021Add 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
25000-021-08	2500000210825000002108	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-08)Marketed from Oct 1, 2016
25000-021-13	2500000211325000002113	600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-13)Marketed from Oct 1, 2016
25000-021-21	2500000212125000002121	4 BAG in 1 BOX (25000-021-21) / 7500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Oct 1, 2016
25000-021-34	2500000213425000002134	28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (25000-021-34)Marketed from Oct 1, 2016
25000-021-36	2500000213625000002136	3 BLISTER PACK in 1 CARTON (25000-021-36) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 17, 2020
25000-021-46	2500000214625000002146	8 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-021-46)Marketed from Oct 1, 2016

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 — 10 mg/1
Dosage form: Capsule, Liquid filled
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 206214
Marketing start: Oct 1, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 25000-021_adf6c78c-edb1-4ffb-a934-d8cb772e621fSPL ID adf6c78c-edb1-4ffb-a934-d8cb772e621fSPL set ID c30907f9-1761-41e5-bd4e-2613e756e1c6RxCUI 828269UNII 7AJO3BO7QNUPC 0325000021368, 0325000021344

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

N425000002108 followed by a unit qualifier and the quantity

Package 25000-0021-08. 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 15, 2021.

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 25000-021

What is NDC 25000-021?: 25000-021 is the product NDC for Loratadine, Loratadine 10 mg/1 capsule, liquid filled, listed with the FDA by MARKSANS PHARMA LIMITED. It has 6 package NDCs, 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?: 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?: 109 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 110 Loratadine NDCs

Other NDCs under ANDA 206214

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

FDA NDC Directory listings under ANDA 206214
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefloratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	TARGET CORPORATION	11673-986
Allergy Reliefloratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	Safeway	21130-195
Allergy Reliefloratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0755
Allergy Reliefloratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	CHAIN DRUG MARKETING ASSOCIATION, INC.	83324-103
Loratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	KROGER COMPANY	41226-686
Loratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	TIME CAP LABORATORIES INC	49483-686
Loratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	SMART SENSE (KMART)	49738-686
Loratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	CVS HEALTH CORP	69842-686
Wal-Itinloratadine	Loratadine 10 mg/1	Capsule, Liquid filledOral	WALGREENS	0363-1686