Over-the-counter drug · ANDA

levocetirizine dihydrochloride NDC 0363-5529

Levocetirizine dihydrochloride 5 mg/1 · Tablet, Coated · Oral · Walgreens Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-5529Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-5529Add 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
0363-5529-1000363552910003635529102 BLISTER PACK in 1 CARTON (0363-5529-10) / 5 TABLET, COATED in 1 BLISTER PACKMarketed from Apr 17, 2018
0363-5529-1200363552912003635529121 BOTTLE in 1 CARTON (0363-5529-12) / 120 TABLET, COATED in 1 BOTTLEMarketed from Jan 15, 2021
0363-5529-3500363552935003635529351 BOTTLE in 1 CARTON (0363-5529-35) / 35 TABLET, COATED in 1 BOTTLEMarketed from Mar 26, 2018
0363-5529-5500363552955003635529551 BOTTLE in 1 CARTON (0363-5529-55) / 55 TABLET, COATED in 1 BOTTLEMarketed from Mar 26, 2018
0363-5529-8000363552980003635529801 BOTTLE in 1 CARTON (0363-5529-80) / 80 TABLET, COATED in 1 BOTTLEMarketed from Mar 26, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
levocetirizine dihydrochloride
Generic name (nonproprietary)
levocetirizine dihydrochloride
Active ingredients
Levocetirizine dihydrochloride — 5 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Walgreens CompanyNDC labeler code 0363
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 0363-5529_7d5d0782-387a-6951-f77d-da28a0065fefSPL ID 7d5d0782-387a-6951-f77d-da28a0065fefSPL set ID 766b8836-74b8-8af7-b900-b813b4fc175bRxCUI 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

N400363552910 followed by a unit qualifier and the quantity

Package 00363-5529-10. 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 0363-5529

What is NDC 0363-5529?
0363-5529 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, coated, listed with the FDA by Walgreens Company. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
levocetirizine dihydrochloride.
What is the active ingredient?
Levocetirizine dihydrochloride.
Who is the labeler?
Walgreens Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for levocetirizine dihydrochloride?
59 other product NDCs are listed under this name. See all levocetirizine dihydrochloride 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 levocetirizine dihydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralFarmacias De Similares TX LLC85786-20685786-0206-30
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-881068788-8810-0168788-8810-0368788-8810-06+1 more
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralNorthwind Health Company, LLC51655-14851655-0148-52
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-793468788-7934-0168788-7934-0368788-7934-06+1 more
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralNorthwind Health Company, LLC51655-56451655-0564-52
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralCamber Consumer Care Inc69230-32169230-0321-0169230-0321-1069230-0321-31+3 more
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, Film coatedOralSportpharm LLC85766-15285766-0152-35
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralChain Drug Marketing Association INC63868-47363868-0473-35
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralSAM'S WEST INC68196-40668196-0406-20
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralBJWC (Berkley & Jensen / BJ'S)68391-95568391-0955-11

All 60 levocetirizine dihydrochloride 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
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralKROGER COMPANY30142-717
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralChain Drug Marketing Association INC63868-473
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-938
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralDr. Reddy's Laboratories Inc.43598-735
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralDr. Reddy's Laboratories Inc.43598-810
24HR Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralLEADER/ Cardinal Health 110, Inc.70000-0362
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralWalmart Inc.49035-492
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralTarget Corporation11673-847
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralCVS PHARMACY69842-761
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralRite Aid Corporation11822-5252
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralSAM'S WEST INC68196-406
Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralAlbertsons Companies21130-732
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralBJWC (Berkley & Jensen / BJ'S)68391-955
Allergy Relieflevocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralAMERISOURCEBERGEN DRUG CORPORATION46122-531
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralHEB37808-126

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