Levocetirizine Dihydrochloride NDC 71335-0789

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0789Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0789Add 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
71335-0789-1	71335078901	30 TABLET in 1 BOTTLE (71335-0789-1)Marketed from Jan 11, 2019
71335-0789-2	71335078902	90 TABLET in 1 BOTTLE (71335-0789-2)Marketed from May 17, 2018
71335-0789-3	71335078903	28 TABLET in 1 BOTTLE (71335-0789-3)Marketed from Dec 27, 2021
71335-0789-4	71335078904	60 TABLET in 1 BOTTLE (71335-0789-4)Marketed from Dec 27, 2021

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
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091264
Marketing start: Jun 29, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617cSPL ID 4677b1a2-8516-44c2-9d61-0f033b40617cSPL set ID b7bbffcb-5f56-4735-998a-eadd07dfa2cbRxCUI 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

N471335078901 followed by a unit qualifier and the quantity

Package 71335-0789-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 091264

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

FDA NDC Directory listings under ANDA 091264
Product	Strength	Form · route	Labeler	Product NDC
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-023
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-148
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-551
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-1430
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-6979