Prescription drug · ANDA
Meclizine Hydrochloride NDC 82868-058
Meclizine hydrochloride 25 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82868-058-20 | 82868005820 | 20 TABLET in 1 BOTTLE, PLASTIC (82868-058-20)Marketed from Jun 27, 2025 | |
| 82868-058-30 | 82868005830 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-058-30)Marketed from Jun 11, 2024 |
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
- 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 82868-058_56921e73-11c5-90de-e063-6394a90a8882SPL ID 56921e73-11c5-90de-e063-6394a90a8882SPL set ID 1b541252-e8a7-b678-e063-6394a90a34dcRxCUI 995666UNII HDP7W44CIO
- 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
N482868005820followed by a unit qualifier and the quantityPackage 82868-0058-20. 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 .
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.
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 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 Hydrochloridemeclizine | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-441 |
| 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 |