Prescription drug · ANDA
Meclizine Hydrochloride NDC 70710-1161
Meclizine hydrochloride 12.5 mg/1 · Tablet · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1161-0 | 70710116100 | 1000 TABLET in 1 BOTTLE (70710-1161-0)Marketed from Oct 29, 2020 | |
| 70710-1161-1 | 70710116101 | 100 TABLET in 1 BOTTLE (70710-1161-1)Marketed from Oct 29, 2020 | |
| 70710-1161-3 | 70710116103 | 30 TABLET in 1 BOTTLE (70710-1161-3)Marketed from Oct 29, 2020 | |
| 70710-1161-4 | 70710116104 | 10 BLISTER PACK in 1 CARTON (70710-1161-4) / 10 TABLET in 1 BLISTER PACK (70710-1161-2)Marketed from Oct 29, 2020 | |
| 70710-1161-9 | 70710116109 | 90 TABLET in 1 BOTTLE (70710-1161-9)Marketed from Oct 29, 2020 |
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 — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 70710-1161_f084de6d-5e11-4c6e-8643-d0a4a48fc4daSPL ID f084de6d-5e11-4c6e-8643-d0a4a48fc4daSPL set ID 947a03c5-bca0-4d97-90b9-bcd6d6588273RxCUI 995624, 995666UNII HDP7W44CIOUPC 0370710116118
- 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
N470710116100followed by a unit qualifier and the quantityPackage 70710-1161-00. 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 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 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3791 |
| 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 |