What is NDC 0615-8565?

0615-8565 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for levocetirizine dihydrochloride?

57 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

levocetirizine dihydrochloride NDC 0615-8565

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8565Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8565Add 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
0615-8565-39	0061585653900615856539	30 TABLET in 1 BLISTER PACK (0615-8565-39)Marketed from Feb 20, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): levocetirizine dihydrochloride
Generic name (nonproprietary): levocetirizine dihydrochloride
Active ingredients: Levocetirizine dihydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203646
Marketing start: Sep 9, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0615-8565_edb36c02-fd49-4de3-b697-cdb6d14cd314SPL ID edb36c02-fd49-4de3-b697-cdb6d14cd314SPL set ID 51d88b2a-d10d-4e7a-b874-98de48069223RxCUI 855172UNII SOD6A38AGA
Pharmacologic class: Histamine-1 Receptor Antagonist

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

N400615856539 followed by a unit qualifier and the quantity

Package 00615-8565-39. 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 Feb 21, 2025.

Indications (excerpt from the label)

Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8565

What is NDC 0615-8565?: 0615-8565 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: levocetirizine dihydrochloride.
What is the active ingredient?: Levocetirizine dihydrochloride.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for levocetirizine dihydrochloride?: 57 other product NDCs are listed under this name. See all levocetirizine dihydrochloride 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 levocetirizine dihydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Farmacias De Similares TX LLC	85786-206	85786-0206-30
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8810	68788-8810-0168788-8810-0368788-8810-06+1 more
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-148	51655-0148-52
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7934	68788-7934-0168788-7934-0368788-7934-06+1 more
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-564	51655-0564-52
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-152	85766-0152-35
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	Chain Drug Marketing Association INC	63868-473	63868-0473-35
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	SAM'S WEST INC	68196-406	68196-0406-20
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	BJWC (Berkley & Jensen / BJ'S)	68391-955	68391-0955-11
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	Rite Aid Corporation	11822-5252	11822-5252-0111822-5252-07

All 58 levocetirizine dihydrochloride NDCs

Other NDCs under ANDA 203646

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

FDA NDC Directory listings under ANDA 203646
Product	Strength	Form · route	Labeler	Product NDC
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Vensun Pharmaceuticals, Inc.	42543-712
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-136
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-892
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-564
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Proficient Rx LP	63187-663
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-8500
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2406
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7934
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Westminster Pharmaceuticals, LLC	69367-238
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Proficient Rx LP	71205-476
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Proficient Rx LP	71205-988
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	71335-0940
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1952
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	71335-2283
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1525