Prescription drug · ANDA
Meclizine Hydrochloride (meclizine) NDC 59651-807
Meclizine hydrochloride 12.5 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-807-01 | 59651080701 | 100 TABLET in 1 BOTTLE (59651-807-01)Marketed from Sep 14, 2023 | |
| 59651-807-99 | 59651080799 | 1000 TABLET in 1 BOTTLE (59651-807-99)Marketed from Sep 14, 2023 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202640
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 59651-807_beb3c7f2-c0f4-41d9-a903-63a6847e0997SPL ID beb3c7f2-c0f4-41d9-a903-63a6847e0997SPL set ID beb3c7f2-c0f4-41d9-a903-63a6847e0997RxCUI 995624, 995666, 995686UNII 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
N459651080701followed by a unit qualifier and the quantityPackage 59651-0807-01. 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 202640
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 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4170 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-808 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-809 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3141 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 12.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8514 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7417 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3157 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7416 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8515 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 25 mg/1 | TabletOral | Redpharm Drug | 67296-2205 |
| Meclizine Hydrochloridemeclizine | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Redpharm Drug | 67296-2250 |