Prescription drug · ANDA
Cetirizine Hydrochloride Oral Solution NDC 68788-8890
Cetirizine hydrochloride 1 mg/mL · Solution · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8890-1 | 68788889001 | 120 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
- Brand name (proprietary)
- Cetirizine Hydrochloride Oral Solution
- Generic name (nonproprietary)
- cetirizine hydrochloride oral solution
- Active ingredients
- Cetirizine hydrochloride — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- 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
N468788889001followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 078870
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cetirizine Hydrochloride Oral Solution | Cetirizine hydrochloride 1 mg/mL | SolutionOral | APOZEAL PHARMACEUTICALS INC | 83745-185 |