Prescription drug · ANDA
Meclizine Hydrochloride (meclizine) NDC 65162-441
Meclizine hydrochloride 12.5 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-441-03 | 65162044103 | 30 TABLET in 1 BOTTLE (65162-441-03)Marketed from Feb 12, 2010 | |
| 65162-441-10 | 65162044110 | 100 TABLET in 1 BOTTLE (65162-441-10)Marketed from Feb 12, 2010 | |
| 65162-441-11 | 65162044111 | 1000 TABLET in 1 BOTTLE (65162-441-11)Marketed from Feb 12, 2010 | |
| 65162-441-50 | 65162044150 | 500 TABLET in 1 BOTTLE (65162-441-50)Marketed from Feb 12, 2010 | |
| 65162-441-60 | 65162044160 | 100 TABLET in 1 BLISTER PACK (65162-441-60)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
- Active ingredients
- Meclizine hydrochloride — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201451
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 65162-441_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
N465162044103followed by a unit qualifier and the quantityPackage 65162-0441-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 201451
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 12.5 mg/1 | TabletOral | AvPAK | 50268-522 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | QPharma Inc | 42708-189 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | AvPAK | 50268-523 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-175 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-058 |
| 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 | American Health Packaging | 60687-730 |
| 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 Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-442 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | QPharma Inc | 42708-127 |
| Meclizine Hydrochloride | Meclizine hydrochloride 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-444 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7376 |