NDC codes

FDA NDC Directory
Product NDC (as listed)68016-995Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0995Add 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
68016-995-0368016099503680160995031 BOTTLE in 1 CARTON (68016-995-03) / 30 TABLET in 1 BOTTLEMarketed from Apr 1, 2014
68016-995-4568016099545680160995451 BOTTLE in 1 CARTON (68016-995-45) / 45 TABLET in 1 BOTTLEMarketed from Apr 1, 2014

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)
Fexofenadine Hydrochloride
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Chain Drug Consortium, LLCNDC labeler code 68016
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076502
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 68016-995_9cb9fb1e-0d5d-763a-4950-4b0d53a5b9eeSPL ID 9cb9fb1e-0d5d-763a-4950-4b0d53a5b9eeSPL set ID d1d8d0ec-2bdd-fb07-a051-d6353e3c240cRxCUI 997420UNII 2S068B75ZU
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

N468016099503 followed by a unit qualifier and the quantity

Package 68016-0995-03. 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)

Use(s) Allergy temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Hives reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68016-995

What is NDC 68016-995?
68016-995 is the product NDC for Fexofenadine Hydrochloride, Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by Chain Drug Consortium, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fexofenadine Hydrochloride.
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
Chain Drug Consortium, LLC, NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fexofenadine Hydrochloride?
42 other product NDCs are listed under this name. See all Fexofenadine 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 Fexofenadine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fexofenadine Hydrochloridefexofenadine hydrochloride oralFexofenadine hydrochloride 30 mg/5mLSuspensionOralAurohealth LLC58602-42758602-0427-2058602-0427-24
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralNUVICARE LLC84324-04584324-0045-01
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA Corp73581-02573581-0025-0173581-0025-0673581-0025-20
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-02673581-0026-0173581-0026-1073581-0026-20
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-02773581-0027-0173581-0027-0473581-0027-10+1 more
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAMZ789 LLC73629-00873629-0008-03
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-00884324-0008-01
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAMERISOURCE BERGEN46122-77946122-0779-5846122-0779-6146122-0779-66
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralPioneer Life Sciences, LLC72090-01072090-0010-01
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1Tablet, Film coatedOralGranules India Limited62207-88962207-0889-4962207-0889-5162207-0889-60

All 43 Fexofenadine Hydrochloride NDCs

Other NDCs under ANDA 076502

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

FDA NDC Directory listings under ANDA 076502
ProductStrengthForm · routeLabelerProduct NDC
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralRite Aid Corporation11822-3698
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSafeway Inc21130-784
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralFamily Dollar Stores, Inc.55319-917
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralWalgreens Company0363-0783
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralKROGER COMPANY30142-878
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDr. Reddy's Laboratories Inc.43598-809
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralDr. Reddy's Laboratories Inc.43598-936
Fexofenadine hydrochlorideFexofenadine hydrochloride 30 mg/1TabletOralDr. Reddy's Laboratories Limited55111-782
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralDr. Reddy's Laboratories Limited55111-783
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDr. Reddy's Laboratories Limited55111-784
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDollar General55910-111
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralChain Drug Marketing Associate63868-025
Fexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralBluePoint Laboratories68001-439
Fexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralBluePoint Laboratories68001-440
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralSam's West Inc.68196-107
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCVS Health Corp.69842-052
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralStrategic Sourcing Services, LLC70677-1009
Non-Drowsy Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralTARGET CORPORATION11673-621
Wal-Fexfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralWalgreens Company0363-0784

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