Over-the-counter drug · ANDA

Allergy Relief (Fexofenadine hydrochloride) NDC 83324-095

Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · CHAIN DRUG MARKETING ASSOCIATION, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)83324-095Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83324-0095Add 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
83324-095-1583324009515833240095153 BLISTER PACK in 1 CARTON (83324-095-15) / 5 TABLET in 1 BLISTER PACKMarketed from Aug 16, 2024
83324-095-3083324009530833240095301 BOTTLE, PLASTIC in 1 CARTON (83324-095-30) / 30 TABLET in 1 BOTTLE, PLASTICMarketed from Aug 16, 2024
83324-095-4583324009545833240095451 BOTTLE, PLASTIC in 1 CARTON (83324-095-45) / 45 TABLET in 1 BOTTLE, PLASTICMarketed from Aug 16, 2024

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)
Allergy Relief
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet
Route
Oral
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.NDC labeler code 83324
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211075
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 83324-095_1fd10e81-a917-79e0-e063-6394a90ac51cSPL ID 1fd10e81-a917-79e0-e063-6394a90ac51cSPL set ID 5059ffc9-b116-4d11-9678-56c696f4e3dbRxCUI 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

N483324009515 followed by a unit qualifier and the quantity

Package 83324-0095-15. 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 83324-095

What is NDC 83324-095?
83324-095 is the product NDC for Allergy Relief (fexofenadine hydrochloride), Fexofenadine hydrochloride 180 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?
Allergy Relief (Fexofenadine Hydrochloride).
What is the active ingredient?
Fexofenadine hydrochloride.
Who is the labeler?
CHAIN DRUG MARKETING ASSOCIATION, INC., NDC labeler code 83324. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Allergy Relief?
271 other product NDCs are listed under this name. See all Allergy Relief 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 Allergy Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralFamora Inc.87509-000387509-0003-06
Allergy Relieflevocetirizine dihydrochloride usp, 5 mgLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralTopco Associates, LLC76162-91576162-0915-3576162-0915-80
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-39172288-0391-0172288-0391-78
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1CapsuleOralCARDINAL HEALTH 110, LLC. DBA LEADER70000-077170000-0771-0170000-0771-02
Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-78472288-0784-27
Allergy ReliefloratadineLoratadine 10 mg/1Tablet, Orally disintegratingOralMeijer, Inc.79481-972379481-9723-01
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralDr. Reddy's Laboratories Inc.75907-43475907-0434-0175907-0434-30
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralKroger Company30142-85630142-0856-62
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-04084324-0040-01
Allergy Reliefcetirizine tabletsCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDISCOUNT DRUG MART, INC53943-13053943-0130-1353943-0130-17

All 272 Allergy Relief NDCs

Other NDCs under ANDA 211075

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

FDA NDC Directory listings under ANDA 211075
ProductStrengthForm · routeLabelerProduct NDC
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralGrocery Outlet, Inc.85828-192
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralTARGET CORPORATION11673-767
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralUnited Natural Foods, Inc. dba UNFI41163-292
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralBi-Mart37835-602
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralTOPCO ASSOCIATES LLC36800-653
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralAAA PHARMACEUTICAL, INC.57344-292
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralSafeway, Inc21130-769
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7660
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA Corp73581-025
Fexofenadine HClFexofenadine hydrochloride 60 mg/1TabletOralRite Aid11822-7652
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7661
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-026
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7663
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7664
Crcle Fexofenadine Hydrochloridefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-240
Crcle Fexofenadine Hydrochloridefexofenadine hydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralInnovus Pharmaceuticals, Inc.57483-230
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralCVS51316-767
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralCVS51316-768
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralGranules India Limited62207-623
ValuMeds 24-Hour Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCabinet Health P.B.C.82725-1002

Showing 20 of 39.

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