Prescription drug · ANDA
Mexiletine Hydrochloride NDC 0093-8739
Mexiletine hydrochloride 150 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-8739-01 | 00093873901 | 100 CAPSULE in 1 BOTTLE (0093-8739-01)Marketed from Jun 5, 1995 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074377
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-8739_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9SPL ID e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9SPL set ID 693da40b-26d4-40d6-87d1-158e256f40abRxCUI 1362706, 1362712, 1362720UNII 606D60IS38UPC 0300938741014, 0300938739011
- 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
N400093873901followed by a unit qualifier and the quantityPackage 00093-8739-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Mexiletine hydrochloride capsules 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 074377
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 250 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-8741 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-8740 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | AvKARE | 42291-626 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | AvKARE | 42291-624 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | AvKARE | 42291-625 |