NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8890Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8890Add 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 NDC11-digit (billing)PackageCopy
68788-8890-16878888900168788889001120 mL in 1 BOTTLE (68788-8890-1)Marketed from Jun 27, 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

Generic name (nonproprietary)
cetirizine hydrochloride oral solution
Active ingredients
Cetirizine hydrochloride — 1 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078870
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 68788-8890_a03d33dc-a84c-4ab7-88a8-77333bfcb8e7SPL ID a03d33dc-a84c-4ab7-88a8-77333bfcb8e7SPL set ID a03d33dc-a84c-4ab7-88a8-77333bfcb8e7RxCUI 1014673UNII 64O047KTOA
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

N468788889001 followed by a unit qualifier and the quantity

Package 68788-8890-01. 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 .

Indications (excerpt from the label)

INDICATIONS & USAGE Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly red…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8890

What is NDC 68788-8890?
68788-8890 is the product NDC for Cetirizine Hydrochloride Oral Solution, Cetirizine hydrochloride 1 mg/mL solution, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cetirizine Hydrochloride Oral Solution.
What is the active ingredient?
Cetirizine hydrochloride.
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 Cetirizine Hydrochloride Oral Solution?
2 other product NDCs are listed under this name. See all Cetirizine Hydrochloride Oral Solution 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 Cetirizine Hydrochloride Oral Solution NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cetirizine Hydrochloride Oral SolutionCetirizine hydrochloride 1 mg/mLSolutionOralAPOZEAL PHARMACEUTICALS INC83745-18583745-0185-0483745-0185-0883745-0185-16
Cetirizine Hydrochloride Oral SolutionCetirizine hydrochloride 5 mg/5mLSolutionOralChartwell RX, LLC62135-05762135-0057-4162135-0057-47

Other NDCs under ANDA 078870

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

FDA NDC Directory listings under ANDA 078870
ProductStrengthForm · routeLabelerProduct NDC
Cetirizine Hydrochloride Oral SolutionCetirizine hydrochloride 1 mg/mLSolutionOralAPOZEAL PHARMACEUTICALS INC83745-185

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