What is NDC 10135-639?

10135-639 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Marlex Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Marlex Pharmaceuticals Inc, NDC labeler code 10135. 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 10135-639

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-639Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0639Add 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	Copy
10135-639-30	1013506393010135063930	30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30)Marketed from Sep 1, 2018
10135-639-90	1013506399010135063990	90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90)Marketed from Sep 1, 2018

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, Film coated
Route: Oral
Labeler: Marlex Pharmaceuticals IncNDC labeler code 10135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202046
Marketing start: Sep 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5SPL ID f380ef7e-eece-412d-b50c-deae2f6098d5SPL set ID f5d8d6a6-6455-430b-8923-090e1ca2ae3bRxCUI 855172UNII SOD6A38AGAUPC 0310135639304, 0310135639908
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

N410135063930 followed by a unit qualifier and the quantity

Package 10135-0639-30. 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 Jan 1, 2018.

Indications (excerpt from the label)

Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) The treatment of the uncomplicated skin manifestations of chronic idiopathicurticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older. 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablet 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 10135-639

What is NDC 10135-639?: 10135-639 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Marlex Pharmaceuticals Inc. It has 2 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?: Marlex Pharmaceuticals Inc, NDC labeler code 10135. 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 202046

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

FDA NDC Directory listings under ANDA 202046
Product	Strength	Form · route	Labeler	Product NDC
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-122
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5107
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-210
Levocetirizine Dihydrochloride	Levocetirizine dihydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1305