MEXILETINE HYDROCHLORIDE
- Product NDC
- 71335-2922
- 11-digit product format
- 713352922
- Labeler code
- 71335
- Product ID
- 71335-2922_4a39d28c-d525-48bf-b5f5-a19511f100bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mexiletine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA214089
- Marketing category
- ANDA
- Marketing start
- 2021-11-29
- Substance
- MEXILETINE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- MEXILETINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| MEXILETINE HYDROCHLORIDE | 150 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 606D60IS38 |
| Rxcui | 1362706 |
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 |
|---|
| 71335-2922-1 | 71335292201 | 100 CAPSULE in 1 BOTTLE (71335-2922-1) | 100 capsule | 2025-11-06 | No | No | Historical |