What is NDC 68788-8810?

68788-8810 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?

59 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 68788-8810

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8810Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8810Add 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
68788-8810-1	6878888100168788881001	100 TABLET, FILM COATED in 1 BOTTLE (68788-8810-1)Marketed from Jan 20, 2025
68788-8810-3	6878888100368788881003	30 TABLET, FILM COATED in 1 BOTTLE (68788-8810-3)Marketed from Jan 20, 2025
68788-8810-6	6878888100668788881006	60 TABLET, FILM COATED in 1 BOTTLE (68788-8810-6)Marketed from Jan 20, 2025
68788-8810-9	6878888100968788881009	90 TABLET, FILM COATED in 1 BOTTLE (68788-8810-9)Marketed from Jan 20, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205564
Marketing start: Jan 20, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68788-8810_5d6941c7-ef0a-48d3-93dc-53bc2c9789deSPL ID 5d6941c7-ef0a-48d3-93dc-53bc2c9789deSPL set ID 5d6941c7-ef0a-48d3-93dc-53bc2c9789deRxCUI 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

N468788881001 followed by a unit qualifier and the quantity

Package 68788-8810-01. 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 Jan 20, 2025.

Indications (excerpt from the label)

Levocetirizine dihydrochloride tablets are 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 month of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8810

What is NDC 68788-8810?: 68788-8810 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?: 59 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	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	Camber Consumer Care Inc	69230-321	69230-0321-0169230-0321-1069230-0321-31+3 more
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 60 Levocetirizine Dihydrochloride NDCs

Other NDCs under ANDA 205564

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

FDA NDC Directory listings under ANDA 205564
Product	Strength	Form · route	Labeler	Product NDC
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-200
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0418