Prescription drug · ANDA
Mexiletine hydrochloride NDC 31722-038
Mexiletine hydrochloride 250 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-038-01 | 3172200380131722003801 | 100 CAPSULE in 1 BOTTLE (31722-038-01)Marketed from Nov 9, 2022 |
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 — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216463
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-038_ed93311a-2bfc-3875-e053-2a95a90ac6f0SPL ID ed93311a-2bfc-3875-e053-2a95a90ac6f0SPL set ID 8b20e850-037b-4c16-a57d-c3d4909f147aRxCUI 1362706, 1362712, 1362720UNII 606D60IS38UPC 0331722036016, 0331722037013, 0331722038010
- 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
N431722003801followed by a unit qualifier and the quantityPackage 31722-0038-01. 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 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.
About NDC 31722-038
- What is NDC 31722-038?
- 31722-038 is the product NDC for Mexiletine hydrochloride, Mexiletine hydrochloride 250 mg/1 capsule, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mexiletine hydrochloride.
- What is the active ingredient?
- Mexiletine hydrochloride.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mexiletine hydrochloride?
- 47 other product NDCs are listed under this name. See all Mexiletine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mexiletine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Amerisyn LLC | 87564-052 | 87564-0052-10 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Amerisyn LLC | 87564-053 | 87564-0053-10 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Amerisyn LLC | 87564-054 | 87564-0054-10 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-555 | 33342-0555-1133342-0555-12 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-556 | 33342-0556-1133342-0556-12 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-557 | 33342-0557-1133342-0557-12 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-666 | 64980-0666-01 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-667 | 64980-0667-01 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 250 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-668 | 64980-0668-01 |
| Mexiletine Hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3171 | 71335-3171-0171335-3171-02 |
Other NDCs under ANDA 216463
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 | Camber Pharmaceuticals, Inc. | 31722-036 |
| Mexiletine hydrochloride | Mexiletine hydrochloride 200 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-037 |
| Mexiletine hydrochloride | Mexiletine hydrochloride 150 mg/1 | CapsuleOral | American Health Packaging | 60687-778 |