What is NDC 42571-312?

42571-312 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Micro Labs Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levocetirizine Dihydrochloride NDC 42571-312

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0312Add 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 NDC	11-digit (billing)	Package
42571-312-11	42571031211	100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32)Marketed from Feb 1, 2019
42571-312-18	42571031218	1 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLEMarketed from Feb 1, 2019
42571-312-53	42571031253	2500 TABLET in 1 POUCH (42571-312-53)Marketed from Feb 1, 2019
42571-312-90	42571031290	1 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLEMarketed from Feb 1, 2019

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): Levocetirizine Dihydrochloride
Generic name (nonproprietary): levocetirizine dihydrochloride
Active ingredients: Levocetirizine dihydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211551
Marketing start: Feb 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 42571-312_2e504864-a08d-48e1-e063-6394a90a92edSPL ID 2e504864-a08d-48e1-e063-6394a90a92edSPL set ID 78ff8e86-ee5b-4626-aa81-49e974febf1dRxCUI 855172UNII SOD6A38AGAUPC 0342571312909
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

N442571031211 followed by a unit qualifier and the quantity

Package 42571-0312-11. 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 Feb 16, 2025.

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 42571-312

What is NDC 42571-312?: 42571-312 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Micro Labs Limited. 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?: Micro Labs Limited, NDC labeler code 42571. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Farmacias De Similares TX LLC	85786-206	85786-0206-30
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8810	68788-8810-0168788-8810-0368788-8810-06+1 more
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-148	51655-0148-52
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7934	68788-7934-0168788-7934-0368788-7934-06+1 more
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-564	51655-0564-52
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Camber Consumer Care Inc	69230-321	69230-0321-0169230-0321-1069230-0321-31+3 more
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-152	85766-0152-35
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	SAM'S WEST INC	68196-406	68196-0406-20
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	BJWC (Berkley & Jensen / BJ'S)	68391-955	68391-0955-11
levocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, CoatedOral	Chain Drug Marketing Association INC	63868-473	63868-0473-35

All 60 Levocetirizine Dihydrochloride NDCs

Other NDCs under ANDA 211551

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

FDA NDC Directory listings under ANDA 211551
Product	Strength	Form · route	Labeler	Product NDC
Allergy Relief 24HRlevocetirizine dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	TabletOral	VELOCITY PHARMA LLC	76168-501