Prescription drug · ANDA
Meclizine Hydrochloride (meclizine hydrocloride) NDC 76420-130
Meclizine hydrochloride 25 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-130-10 | 76420013010 | 10 TABLET in 1 BOTTLE (76420-130-10)Marketed from Oct 30, 2020 | |
| 76420-130-20 | 76420013020 | 20 TABLET in 1 BOTTLE (76420-130-20)Marketed from Oct 30, 2020 | |
| 76420-130-30 | 76420013030 | 30 TABLET in 1 BOTTLE (76420-130-30)Marketed from Oct 30, 2020 |
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 hydrocloride
- Active ingredients
- Meclizine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040659
- Marketing start
- Listing expires
- Other FDA classes
- Emesis Suppression (Physiologic effect)
- Identifiers
- Product ID 76420-130_b2ddcdd0-726a-99df-e053-2a95a90a8818SPL ID b2ddcdd0-726a-99df-e053-2a95a90a8818SPL set ID 5c70e61b-a1e6-4981-92e2-1050cee08baaRxCUI 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
N476420013010followed by a unit qualifier and the quantityPackage 76420-0130-10. 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 is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride is 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 040659
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 Hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | QPharma Inc | 42708-102 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1690 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-996 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3017 |
| Meclizine Hydrochloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-107 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-121 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Jubilant Cadista Pharmacuticals Inc. | 59746-122 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Proficient Rx LP | 71205-416 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0503 |
| Meclizine Hydrochloridemeclizine hydrocloride | Meclizine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1308 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1563 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2432 |
| Meclizine Hydrochloride | Meclizine hydrochloride 12.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0153 |