Prescription drug · ANDA
Meclizine Hydrochloride NDC 50268-523
Meclizine hydrochloride 25 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-523-15 | 50268052315 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-523-15) / 1 TABLET in 1 BLISTER PACK (50268-523-11)Marketed from Aug 8, 2013 |
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
- AvPAK
- 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 50268-523_47e73600-a8db-31d6-e063-6294a90a47f3SPL ID 47e73600-a8db-31d6-e063-6294a90a47f3SPL set ID af5d0c9b-a997-8033-afca-3c04221f2e76RxCUI 995624, 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
N450268052315followed by a unit qualifier and the quantityPackage 50268-0523-15. 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)
INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.
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 | 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 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 |