NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9612Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9612Add 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
71335-9612-17133596120130 TABLET, FILM COATED in 1 BOTTLE (71335-9612-1)Marketed from Jan 3, 2023
71335-9612-27133596120214 TABLET, FILM COATED in 1 BOTTLE (71335-9612-2)Marketed from Jan 3, 2023
71335-9612-3713359612037 TABLET, FILM COATED in 1 BOTTLE (71335-9612-3)Marketed from Jan 3, 2023
71335-9612-47133596120410 TABLET, FILM COATED in 1 BOTTLE (71335-9612-4)Marketed from Jan 3, 2023
71335-9612-57133596120515 TABLET, FILM COATED in 1 BOTTLE (71335-9612-5)Marketed from Jan 3, 2023
71335-9612-67133596120690 TABLET, FILM COATED in 1 BOTTLE (71335-9612-6)Marketed from Jan 3, 2023
71335-9612-77133596120720 TABLET, FILM COATED in 1 BOTTLE (71335-9612-7)Marketed from Jan 3, 2023
71335-9612-87133596120860 TABLET, FILM COATED in 1 BOTTLE (71335-9612-8)Marketed from Jan 3, 2023
71335-9612-971335961209100 TABLET, FILM COATED in 1 BOTTLE (71335-9612-9)Marketed from Jan 3, 2023

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
Generic name (nonproprietary)
cetirizine hydrochloride tablets
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078343
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 71335-9612_feff9aa9-70f0-4e25-a822-f219cd1dde9aSPL ID feff9aa9-70f0-4e25-a822-f219cd1dde9aSPL set ID e4324124-13f8-4450-9fd6-686bd6e25578RxCUI 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

N471335961201 followed by a unit qualifier and the quantity

Package 71335-9612-01. 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 078343

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

FDA NDC Directory listings under ANDA 078343
ProductStrengthForm · routeLabelerProduct NDC
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-045
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralVERITYRX, LLC83939-0004
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-709
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDr.Reddy's Laboratories Limited55111-351
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-801
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-183
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8435
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDr. Reddy's Laboratories Inc.43598-811
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDiscount Drug Mart, Inc53943-519
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDr.Reddy's Laboratories Limited55111-699
cetirizine hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1007

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