What is NDC 65162-442?

65162-442 is the product NDC for Meclizine Hydrochloride, Meclizine hydrochloride 25 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Meclizine Hydrochloride?

83 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Meclizine Hydrochloride NDC 65162-442

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-442Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0442Add 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
65162-442-03	6516204420365162044203	30 TABLET in 1 BOTTLE (65162-442-03)Marketed from Feb 12, 2010
65162-442-10	6516204421065162044210	100 TABLET in 1 BOTTLE (65162-442-10)Marketed from Feb 12, 2010
65162-442-11	6516204421165162044211	1000 TABLET in 1 BOTTLE (65162-442-11)Marketed from Feb 12, 2010
65162-442-50	6516204425065162044250	500 TABLET in 1 BOTTLE (65162-442-50)Marketed from Feb 12, 2010
65162-442-60	6516204426065162044260	100 TABLET in 1 BLISTER PACK (65162-442-60)Marketed from Feb 12, 2010

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): Meclizine Hydrochloride
Generic name (nonproprietary): meclizine hydrochloride
Active ingredients: Meclizine hydrochloride — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201451
Marketing start: Feb 12, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Emesis Suppression (Physiologic effect)
Identifiers: Product ID 65162-442_50a794d1-8c02-4419-a037-de9d3825d342SPL ID 50a794d1-8c02-4419-a037-de9d3825d342SPL set ID 666dc4d8-7b16-4c3c-84e4-645548dbee68RxCUI 995624, 995666, 995686UNII HDP7W44CIOUPC 0365162444032, 0365162442038, 0365162441031
Pharmacologic class: Antiemetic

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

N465162044203 followed by a unit qualifier and the quantity

Package 65162-0442-03. 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 Sep 28, 2023.

Indications (excerpt from the label)

Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-442

What is NDC 65162-442?: 65162-442 is the product NDC for Meclizine Hydrochloride, Meclizine hydrochloride 25 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Meclizine Hydrochloride.
What is the active ingredient?: Meclizine hydrochloride.
Who is the labeler?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Meclizine Hydrochloride?: 83 other product NDCs are listed under this name. See all Meclizine 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 Meclizine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 25 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-997	60760-0997-30
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-0869	67046-0869-03
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 25 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4170	68788-4170-0168788-4170-03
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 50 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-943	23155-0943-0123155-0943-10
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0494	80425-0494-0180425-0494-0280425-0494-03
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-058	82868-0058-2082868-0058-30
Meclizine Hydrochloride	Meclizine hydrochloride 12.5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8633	68788-8633-0168788-8633-03
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 25 mg/1	TabletOral	A-S Medication Solutions	50090-7417	50090-7417-0050090-7417-0150090-7417-04+1 more
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 25 mg/1	TabletOral	A-S Medication Solutions	50090-7416	50090-7416-02
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 50 mg/1	TabletOral	Aurobindo Pharma Limited	59651-809	59651-0809-0559651-0809-90

All 84 Meclizine Hydrochloride NDCs

Other NDCs under ANDA 201451

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

FDA NDC Directory listings under ANDA 201451
Product	Strength	Form · route	Labeler	Product NDC
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Major Pharmaceuticals	0904-7376
Meclizine Hydrochloride	Meclizine hydrochloride 50 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-444
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	AvPAK	50268-523
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 12.5 mg/1	TabletOral	AvPAK	50268-522
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	51655-175
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	QPharma Inc	42708-127
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	QPharma Inc	42708-189
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	American Health Packaging	60687-730
Meclizine Hydrochloride	Meclizine hydrochloride 12.5 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-441
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-442
Meclizine Hydrochloride	Meclizine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-058
Meclizine Hydrochloride	Meclizine hydrochloride 12.5 mg/1	TabletOral	American Health Packaging	60687-775
Meclizine Hydrochloride	Meclizine hydrochloride 12.5 mg/1	TabletOral	Major Pharmaceuticals	0904-7375
Meclizine Hydrochloridemeclizine	Meclizine hydrochloride 12.5 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-441