Over-the-counter drug · ANDA

Cetirizine Hydrochloride NDC 55111-351

Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Dr.Reddy's Laboratories Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)55111-351Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0351Add 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
55111-351-04551110351041 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008
55111-351-30551110351301 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008
55111-351-45551110351451 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008
55111-351-47551110351472 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008
55111-351-51551110351511 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008
55111-351-60551110351601 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008
55111-351-74551110351742 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 15, 2008
55111-351-90551110351901 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
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 55111-351_000d3a47-3836-b678-9487-2bbc518cd57fSPL ID 000d3a47-3836-b678-9487-2bbc518cd57fSPL set ID de152651-bfcd-856a-8329-a2ac93a376bcRxCUI 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

N455111035104 followed by a unit qualifier and the quantity

Package 55111-0351-04. 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)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy,watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 coatedOralBryant Ranch Prepack71335-9612
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-709
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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