Prescription drug · ANDA
Meclizine Hydrochloride NDC 68071-3791
Meclizine hydrochloride 25 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3791-2 | 68071379102 | 20 TABLET in 1 BOTTLE (68071-3791-2)Marketed from Feb 13, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213957
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 68071-3791_2e0ed208-075d-a301-e063-6294a90a84e2SPL ID 2e0ed208-075d-a301-e063-6294a90a84e2SPL set ID 2e0ed1fc-53e6-a3b1-e063-6394a90af419RxCUI 995666UNII HDP7W44CIOUPC 0368071379129
- 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
N468071379102followed by a unit qualifier and the quantityPackage 68071-3791-02. 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 213957
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 Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Redpharm Drug | 67296-2138 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Redpharm Drug | 67296-2138 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1162 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1161 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3748 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5728 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-5727 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1539 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1540 |