Cetirizine Hydrochloride (cetirizine hydrochloride tablets) NDC 68788-8435

Product information

Brand name (proprietary)

Cetirizine Hydrochloride

Generic name (nonproprietary)

cetirizine hydrochloride tablets

Active ingredients

Cetirizine hydrochloride — 10 mg/1

Dosage form

Tablet, Film coated

Route

Oral

Labeler

Preferred Pharmaceuticals Inc.

Product type

Over-the-counter drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 078343

Marketing start

Apr 27, 2023

Listing expires

Dec 31, 2027

Other FDA classes

Histamine H1 Receptor Antagonists (Mechanism)

Identifiers

Product ID 68788-8435_8efeffe6-f264-4a44-a348-63a33f9c6d25SPL ID 8efeffe6-f264-4a44-a348-63a33f9c6d25SPL set ID 14a885e5-5e75-4a18-b5bc-6aaa748712dbRxCUI 1014678UNII 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

N468788843503 followed by a unit qualifier and the quantity Copy

Package 68788-8435-03. 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

Other NDCs under ANDA 078343

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