NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0789Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0789Add 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
71335-0789-1713350789017133507890130 TABLET in 1 BOTTLE (71335-0789-1)Marketed from Jan 11, 2019
71335-0789-2713350789027133507890290 TABLET in 1 BOTTLE (71335-0789-2)Marketed from May 17, 2018
71335-0789-3713350789037133507890328 TABLET in 1 BOTTLE (71335-0789-3)Marketed from Dec 27, 2021
71335-0789-4713350789047133507890460 TABLET in 1 BOTTLE (71335-0789-4)Marketed from Dec 27, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091264
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617cSPL ID 4677b1a2-8516-44c2-9d61-0f033b40617cSPL set ID b7bbffcb-5f56-4735-998a-eadd07dfa2cbRxCUI 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

N471335078901 followed by a unit qualifier and the quantity

Package 71335-0789-01. 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)

Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0789

What is NDC 71335-0789?
71335-0789 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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?
57 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 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
levocetirizine dihydrochlorideLevocetirizine dihydrochloride 5 mg/1Tablet, CoatedOralRite Aid Corporation11822-525211822-5252-0111822-5252-07

All 58 Levocetirizine Dihydrochloride NDCs

Other NDCs under ANDA 091264

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

FDA NDC Directory listings under ANDA 091264
ProductStrengthForm · routeLabelerProduct NDC
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-551
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralA-S Medication Solutions50090-1430
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralA-S Medication Solutions50090-6979
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralNorthwind Health Company, LLC51655-148
Levocetirizine DihydrochlorideLevocetirizine dihydrochloride 5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-023

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