What is NDC 49483-682?

49483-682 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 5 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cetirizine Hydrochloride?

104 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cetirizine Hydrochloride NDC 49483-682

NDC codes

FDA NDC Directory

Product NDC (as listed)49483-682Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49483-0682Add 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
49483-682-01	4948306820149483068201	100 TABLET in 1 BOTTLE (49483-682-01)Marketed from May 30, 2022

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): Cetirizine Hydrochloride
Generic name (nonproprietary): cetirizine hydrochloride
Active ingredients: Cetirizine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: TIME CAP LABORATORIES, INC.NDC labeler code 49483
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078933
Marketing start: May 30, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6SPL ID dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6SPL set ID dfbddafb-9455-5805-e053-2a95a90ad0d9RxCUI 1014676UNII 64O047KTOAUPC 0349483682014
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

N449483068201 followed by a unit qualifier and the quantity

Package 49483-0682-01. 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 May 24, 2022.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper 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 49483-682

What is NDC 49483-682?: 49483-682 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 5 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cetirizine Hydrochloride.
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cetirizine Hydrochloride?: 104 other product NDCs are listed under this name. See all Cetirizine Hydrochloride 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 Cetirizine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cetirizine Hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	First Nation Group, LLC	81469-352	81469-0352-01
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	First Nation Group, LLC	81469-353	81469-0353-0181469-0353-0381469-0353-05+1 more
Cetirizine Hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safecor Health, LLC	48433-017	48433-0017-20
Cetirizine hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Advagen Pharma Ltd.,	72888-480	72888-0480-01
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4072	68788-4072-0368788-4072-0668788-4072-09
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Bionpharma Inc.	69452-426	69452-0426-5569452-0426-88
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-357	57237-0357-1257237-0357-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-358	57237-0358-1257237-0358-24
Cetirizine Hydrochloride	Cetirizine hydrochloride 1 mg/mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-480	61037-0480-2261037-0480-2361037-0480-24+2 more
Cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, CoatedOral	Advanced Rx LLC	80513-731	80513-0731-0580513-0731-12

All 105 Cetirizine Hydrochloride NDCs

Other NDCs under ANDA 078933

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

FDA NDC Directory listings under ANDA 078933
Product	Strength	Form · route	Labeler	Product NDC
All Day Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	DOLGENCORP, INC.	55910-269
Allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Kroger Company	41226-692
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	WALGREENS	0363-1794
Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	BETTER LIVING BRANDS, LLC	21130-712
Cetirizine Hydrochloride Tablets, 10 mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-220
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-160
Cetirizine Hydrochloride Tablets, 5 mgcetirizine hydrochloride	Cetirizine hydrochloride 5 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-219
Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	TIME CAP LABORATORIES, INC.	49483-692
Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-842