NDC codes

FDA NDC Directory
Product NDC (as listed)63187-110Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0110Add 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
63187-110-30631870110306318701103030 TABLET in 1 BOTTLE (63187-110-30)Marketed from Jan 1, 2019
63187-110-60631870110606318701106060 TABLET in 1 BOTTLE (63187-110-60)Marketed from Jul 9, 2021
63187-110-90631870110906318701109090 TABLET in 1 BOTTLE (63187-110-90)Marketed from Jan 1, 2019

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
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077498
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63187-110_c091c3f5-1961-49ad-b4d5-b82062d31e88SPL ID c091c3f5-1961-49ad-b4d5-b82062d31e88SPL set ID d14feb90-3ca2-4d5b-825c-25fc2252ca38RxCUI 1014678UNII 64O047KTOAUPC 0363187110901
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

N463187011030 followed by a unit qualifier and the quantity

Package 63187-0110-30. 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 63187-110

What is NDC 63187-110?
63187-110 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cetirizine Hydrochloride.
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. 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 077498

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

FDA NDC Directory listings under ANDA 077498
ProductStrengthForm · routeLabelerProduct NDC
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralLIDL US, LLC71141-133
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralValu Merchandisers Company63941-939
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralSportpharm LLC85766-205
Quality Choice Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralChain Drug Marketing Association Inc.63868-132
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralOhm Laboratories Inc.51660-939
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralFAMILY DOLLAR SERVICES, INC55319-939
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralChain Drug Consortium, LLC68016-939
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-821
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralMarlex Pharmaceuticals, Inc10135-762
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralMarc Glassman, Inc.68998-939
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2571
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-995
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralPublix Super Markets Inc56062-939

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