NDC codes

FDA NDC Directory
Product NDC (as listed)63868-132Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0132Add 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
63868-132-14638680132146386801321414 TABLET in 1 BLISTER PACK (63868-132-14)Marketed from Dec 27, 2007
63868-132-30638680132306386801323030 TABLET in 1 BOTTLE (63868-132-30)Marketed from Dec 27, 2007
63868-132-90638680132906386801329090 TABLET in 1 BOTTLE (63868-132-90)Marketed from Dec 27, 2007

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

Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Chain Drug Marketing Association Inc.NDC labeler code 63868
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 63868-132_2f9f8dc0-8034-445c-b7b0-bf680a6be979SPL ID 2f9f8dc0-8034-445c-b7b0-bf680a6be979SPL set ID 2e8cc4e3-8386-42de-801f-fef37f612849RxCUI 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

N463868013214 followed by a unit qualifier and the quantity

Package 63868-0132-14. 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 63868-132

What is NDC 63868-132?
63868-132 is the product NDC for Quality Choice Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Chain Drug Marketing Association Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Quality Choice Cetirizine Hydrochloride (Cetirizine Hydrochloride).
What is the active ingredient?
Cetirizine hydrochloride.
Who is the labeler?
Chain Drug Marketing Association Inc., NDC labeler code 63868. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Quality Choice Cetirizine Hydrochloride?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
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/1TabletOralProficient Rx LP63187-110
Cetirizine HydrochlorideCetirizine hydrochloride 10 mg/1TabletOralPublix Super Markets Inc56062-939

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