NDC codes

FDA NDC Directory
Product NDC (as listed)68071-1964Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-1964Add 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
68071-1964-1680711964016807119640110 TABLET in 1 BOTTLE (68071-1964-1)Marketed from Feb 21, 2017
68071-1964-3680711964036807119640330 TABLET in 1 BOTTLE (68071-1964-3)Marketed from Feb 21, 2017
68071-1964-4680711964046807119640414 TABLET in 1 BOTTLE (68071-1964-4)Marketed from Feb 21, 2017
68071-1964-768071196407680711964077 TABLET in 1 BOTTLE (68071-1964-7)Marketed from Feb 21, 2017
68071-1964-9680711964096807119640990 TABLET in 1 BOTTLE (68071-1964-9)Marketed from Feb 21, 2017

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
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NuCare Pharmaceuticals, Inc.NDC labeler code 68071
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077829
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 68071-1964_597fa840-d201-db80-e063-6294a90afcb7SPL ID 597fa840-d201-db80-e063-6294a90afcb7SPL set ID 4913192a-7364-3f19-e054-00144ff8d46cRxCUI 1014678UNII 64O047KTOAUPC 0368071196498
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

N468071196401 followed by a unit qualifier and the quantity

Package 68071-1964-01. 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

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 68071-1964

What is NDC 68071-1964?
68071-1964 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 5 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?
NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 077829

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

FDA NDC Directory listings under ANDA 077829
ProductStrengthForm · routeLabelerProduct NDC
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralProdose, Inc68210-4159
Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1241
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralPioneer Life Sciences, LLC72090-028
Allergy Reliefcetirizine hclCetirizine hydrochloride 10 mg/1TabletOralNUVICARE LLC84324-001
Cabinet All Day Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralCabinet Health P.B.C.82725-3103
Cabinet Allergy Relief Refill Cetirizine HCIcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralCabinet Health P.B.C.82725-3003
Cetirizine HydrochlorideCetirizine hydrochloride 5 mg/1TabletOralRising Pharma Holdings, Inc.16571-401
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralRising Pharma Holdings, Inc.16571-402
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-886
Cetirizine HydrochlorideCetirizine hydrochloride 5 mg/1TabletOralBryant Ranch Prepack63629-4914
Cetirizine HydrochlorideCetirizine hydrochloride 5 mg/1TabletOralProficient Rx LP71205-093
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralProficient Rx LP71205-164
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-0300
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralUmasuto, LLC85293-001
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralSportpharm LLC85766-149
CVS Cetirizine Hydrochloridecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralCVS Pharmacy51316-182
GOOD REMEDIES All Day Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralStrive Pharmaceuticals Inc.70692-801
Goodmeds All Day Allergy Relief Cetirizine HClcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralCabinet Health P.B.C.82725-4103
Indoor and Outdoor Allergy Reliefcetirizine hclCetirizine hydrochloride 25 mg/1Tablet, CoatedOralFamora Inc.87509-0002
RIGHT REMEDIES ALL-DAY Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralStrive Pharmaceuticals Inc.70692-180

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