Over-the-counter drug · ANDA

Cetirizine Hydrochloride (Cetirizine hydrochloride tablets) NDC 43598-811

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

NDC codes

FDA NDC Directory
Product NDC (as listed)43598-811Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0811Add 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
43598-811-0543598081105435980811051 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 17, 2018
43598-811-124359808111243598081112100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12)Marketed from Sep 3, 2019
43598-811-134359808111343598081113300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13)Marketed from Sep 3, 2019
43598-811-154359808111543598081115500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15)Marketed from Sep 3, 2019
43598-811-3043598081130435980811301 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 17, 2018
43598-811-9043598081190435980811901 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 17, 2018

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 tablets
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Dr. Reddy's Laboratories Inc.NDC labeler code 43598
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 43598-811_adfee3f6-660a-305c-2cf4-bd509acfad36SPL ID adfee3f6-660a-305c-2cf4-bd509acfad36SPL set ID e4eca4df-9ad8-b7c4-b512-bfaed5673789RxCUI 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

N443598081105 followed by a unit qualifier and the quantity

Package 43598-0811-05. 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)

About NDC 43598-811

What is NDC 43598-811?
43598-811 is the product NDC for Cetirizine Hydrochloride (cetirizine hydrochloride tablets), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cetirizine Hydrochloride (Cetirizine Hydrochloride Tablets).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine Hydrochloride?
107 other product NDCs are listed under this name. See all Cetirizine Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cetirizine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cetirizine HydrochlorideCetirizine hydrochloride 5 mg/1TabletOralFirst Nation Group, LLC81469-35281469-0352-01
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralFirst Nation Group, LLC81469-35381469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSafecor Health, LLC48433-01748433-0017-20
Cetirizine hydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralAdvagen Pharma Ltd.,72888-48072888-0480-01
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-407268788-4072-0368788-4072-0668788-4072-09
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralBionpharma Inc.69452-42669452-0426-5569452-0426-88
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralRising Pharma Holdings, Inc.57237-35757237-0357-1257237-0357-24
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralRising Pharma Holdings, Inc.57237-35857237-0358-1257237-0358-24
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralBAJAJ MEDICAL, LLC61037-48061037-0480-2261037-0480-2361037-0480-24+2 more
Cetirizine HydrochlorideCetirizine hydrochloride 1 mg/mLSolutionOralBAJAJ MEDICAL, LLC61037-48061037-0480-0261037-0480-0361037-0480-04+2 more

All 108 Cetirizine Hydrochloride NDCs

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 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 coatedOralVERITYRX, LLC83939-0004
cetirizine hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1007
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-045
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDr.Reddy's Laboratories Limited55111-351
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 coatedOralProficient Rx LP71205-709
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9612
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-801
Cetirizine Hydrochloridecetirizine hydrochloride tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8435

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