Over-the-counter drug · ANDA

Allergy Relief (Levocetirizine dihydrochloride) NDC 46122-531

Levocetirizine dihydrochloride 5 mg/1 · Tablet, Coated · Oral · AMERISOURCEBERGEN DRUG CORPORATION

NDC codes

FDA NDC Directory
Product NDC (as listed)46122-531Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0531Add 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
46122-531-05461220531051 BOTTLE in 1 CARTON (46122-531-05) / 35 TABLET, COATED in 1 BOTTLEMarketed from Apr 20, 2018
46122-531-61461220531611 BOTTLE in 1 CARTON (46122-531-61) / 80 TABLET, COATED in 1 BOTTLEMarketed from Sep 1, 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)
levocetirizine dihydrochloride
Active ingredients
Levocetirizine dihydrochloride — 5 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
AMERISOURCEBERGEN DRUG CORPORATIONNDC labeler code 46122
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210375
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 46122-531_7dc5bf93-f17c-3267-33d9-f123f53c072bSPL ID 7dc5bf93-f17c-3267-33d9-f123f53c072bSPL set ID fdf54de3-16a9-3b28-b4c4-d745322b3d3cRxCUI 855172UNII SOD6A38AGA
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

N446122053105 followed by a unit qualifier and the quantity

Package 46122-0531-05. 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 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 46122-531

What is NDC 46122-531?
46122-531 is the product NDC for Allergy Relief (levocetirizine dihydrochloride), Levocetirizine dihydrochloride 5 mg/1 tablet, coated, listed with the FDA by AMERISOURCEBERGEN DRUG CORPORATION. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Allergy Relief (Levocetirizine dihydrochloride).
What is the active ingredient?
Levocetirizine dihydrochloride.
Who is the labeler?
AMERISOURCEBERGEN DRUG CORPORATION, NDC labeler code 46122. 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?
262 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 263 Allergy Relief NDCs

Other NDCs under ANDA 210375

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

FDA NDC Directory listings under ANDA 210375
ProductStrengthForm · routeLabelerProduct NDC
24HR Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralLEADER/ Cardinal Health 110, Inc.70000-0362
Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralAlbertsons Companies21130-732
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralWalgreens Company0363-5529
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralTarget Corporation11673-847
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralRite Aid Corporation11822-5252
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralKROGER COMPANY30142-717
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralHEB37808-126
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-938
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralDr. Reddy's Laboratories Inc.43598-810
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralWalmart Inc.49035-492
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralChain Drug Marketing Association INC63868-473
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralSAM'S WEST INC68196-406
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralBJWC (Berkley & Jensen / BJ'S)68391-955
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralCVS PHARMACY69842-761

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