MEXILETINE HYDROCHLORIDE
- Product NDC
- 82012-028
- 11-digit product format
- 820120028
- Labeler code
- 82012
- Product ID
- 82012-028_dd924d44-b14d-440c-9670-8faa42422ba1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mexiletine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Senores Pharmaceuticals, Inc.
- Application
- ANDA214089
- Marketing category
- ANDA
- Marketing start
- 2021-11-29
- Substance
- MEXILETINE HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 606D60IS38 | MEXILETINE HYDROCHLORIDE | 5370-01-4 | MEXILETINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82012-028-04 | 82012002804 | 100 CAPSULE in 1 BOTTLE (82012-028-04) | 100 capsule | 2021-11-29 | No | No | Historical |