Prescription drug · ANDA
Mexiletine Hydrochloride NDC 64980-667
Mexiletine hydrochloride 200 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-667-01 | 64980066701 | 100 CAPSULE in 1 BOTTLE (64980-667-01)Marketed from Feb 5, 2025 |
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)
- Mexiletine Hydrochloride
- Generic name (nonproprietary)
- mexiletine hydrochloride
- Active ingredients
- Mexiletine hydrochloride — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215315
- Marketing start
- Listing expires
- Identifiers
- Product ID 64980-667_17c65cba-f56f-4cad-a9e2-d31f62e95849SPL ID 17c65cba-f56f-4cad-a9e2-d31f62e95849SPL set ID 17c65cba-f56f-4cad-a9e2-d31f62e95849RxCUI 1362706, 1362712, 1362720UNII 606D60IS38
- Pharmacologic class
- Antiarrhythmic
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
N464980066701followed by a unit qualifier and the quantityPackage 64980-0667-01. 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)
INDICATIONS & USAGE Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215315
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 |
|---|---|---|---|---|
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-666 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-668 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3171 |