Prescription drug · ANDA
Mexiletine Hydrochloride NDC 82012-028
Mexiletine hydrochloride 200 mg/1 · Capsule · Oral · Senores Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82012-028-04 | 82012002804 | 100 CAPSULE in 1 BOTTLE (82012-028-04)Marketed from Nov 29, 2021 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214089
- Marketing start
- Listing expires
- Identifiers
- Product ID 82012-028_dd924d44-b14d-440c-9670-8faa42422ba1SPL ID dd924d44-b14d-440c-9670-8faa42422ba1SPL set ID c4a60f9e-fed1-4172-adc4-0be84ac65db9RxCUI 1362706, 1362712, 1362720UNII 606D60IS38UPC 0382012029041, 0382012027047, 0382012028044
- 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
N482012002804followed by a unit qualifier and the quantityPackage 82012-0028-04. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND 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 arrhythmia…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214089
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 | Bryant Ranch Prepack | 72162-1782 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1783 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1784 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Amerisyn LLC | 87564-054 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Amerisyn LLC | 87564-052 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Amerisyn LLC | 87564-053 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2922 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2928 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Senores Pharmaceuticals, Inc. | 82012-029 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9180 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9179 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9181 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-955 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-956 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-957 |