What is NDC 68462-346?

68462-346 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-346

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-346Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0346Add 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
68462-346-05	68462034605	500 TABLET in 1 BOTTLE (68462-346-05)Marketed from Sep 1, 2026
68462-346-90	68462034690	90 TABLET in 1 BOTTLE (68462-346-90)Marketed from Feb 25, 2011

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): Levocetirizine Dihydrochloride
Generic name (nonproprietary): levocetirizine dihydrochloride
Active ingredients: Levocetirizine dihydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090385
Marketing start: Feb 25, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68462-346_f6e61e6c-802e-4306-aa91-ba0d31665d9eSPL ID f6e61e6c-802e-4306-aa91-ba0d31665d9eSPL set ID 60ae7e0e-281c-40a3-a0d3-259b843ddaaaRxCUI 855172UNII SOD6A38AGAUPC 0368462346907
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

N468462034605 followed by a unit qualifier and the quantity

Package 68462-0346-05. 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 Sep 9, 2026.

Indications (excerpt from the label)

Levocetirizine dihydrochloride tablets are a histamine H 1 -receptor antagonist indicated for: • The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 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 months of age and older.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-346

What is NDC 68462-346?: 68462-346 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 090385

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

FDA NDC Directory listings under ANDA 090385
Product	Strength	Form · route	Labeler	Product NDC
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3841
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Proficient Rx LP	82804-204