Over-the-counter drug · ANDA

Allergy Relief (Fexofenadine hydrochloride) NDC 36800-653

Fexofenadine hydrochloride 180 mg/1 · Tablet · Oral · TOPCO ASSOCIATES LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-653Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0653Add 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
36800-653-03368000653031 BLISTER PACK in 1 CARTON (36800-653-03) / 15 TABLET in 1 BLISTER PACKMarketed from Sep 10, 2021
36800-653-07368000653071 BOTTLE, PLASTIC in 1 CARTON (36800-653-07) / 60 TABLET in 1 BOTTLE, PLASTICMarketed from Dec 8, 2022
36800-653-11368000653111 BOTTLE, PLASTIC in 1 CARTON (36800-653-11) / 150 TABLET in 1 BOTTLE, PLASTICMarketed from Dec 8, 2023

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
TOPCO ASSOCIATES LLCNDC labeler code 36800
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 36800-653_08f3ce32-81a9-f9d2-e063-6394a90ab17dSPL ID 08f3ce32-81a9-f9d2-e063-6394a90ab17dSPL set ID c4f9224c-4c3d-74bd-e053-2995a90a1452RxCUI 997420UNII 2S068B75ZUUPC 0036800492301
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

N436800065303 followed by a unit qualifier and the quantity

Package 36800-0653-03. 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)

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 36800-653

What is NDC 36800-653?
36800-653 is the product NDC for Allergy Relief (fexofenadine hydrochloride), Fexofenadine hydrochloride 180 mg/1 tablet, listed with the FDA by TOPCO ASSOCIATES LLC. 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?
TOPCO ASSOCIATES LLC, NDC labeler code 36800. 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?
263 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 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
Allergy Relieffluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalP & L Development, LLC59726-20359726-0203-3859726-0203-54

All 264 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
Cabinet Allergy Relief Fexofenadinefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCabinet Health P.B.C.82725-3002
Cabinet Allergy Relief Fexofenadinefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCabinet Health P.B.C.82725-3002
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralSafeway, Inc21130-769
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC63868-334
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7661
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralAMERIFOODS TRADING COMPANY61504-192
Fexofenadine HClFexofenadine hydrochloride 60 mg/1TabletOralRite Aid11822-7652
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7660
Fexofenadine HCl 180 mgfexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralFarmacias De Similares TX LLC85786-204
Fexofenadine HCLFexofenadine hydrochloride 180 mg/1TabletOralWalgreens0363-6231
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7663
Fexofenadine HClFexofenadine hydrochloride 180 mg/1TabletOralRite Aid11822-7664
Allergy Relief Non Drowsyfexofenadine hclFexofenadine hydrochloride 180 mg/1CapsuleOralWinCo Foods67091-386
ValuMeds 24-Hour Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralCabinet Health P.B.C.82725-1002
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralYYBA Corp73581-026
Fexofenadine HydrochlorideFexofenadine hydrochloride 60 mg/1TabletOralYYBA Corp73581-025
Allergy Relieffexofenadine hclFexofenadine hydrochloride 180 mg/1TabletOralSafeway, Inc.21130-821
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralMARC GLASSMAN, INC.68998-292
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralNUVICARE LLC84324-040
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1TabletOralDISCOUNT DRUG MART53943-392

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