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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MEXILETINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEXILETINE HYDROCHLORIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 606D60IS38 |
| Rxcui | 1362706, 1362712, 1362720 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82012-028-04 | MEXILETINE HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82012-028 | MEXILETINE HYDROCHLORIDE CAPSULE [SENORES PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230617_c4a60f9e-fed1-4172-adc4-0be84ac65db9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82012-028-04 | 82012002804 | 100 CAPSULE in 1 BOTTLE (82012-028-04) | 100 capsule | 2021-11-29 | 0000-00-00 | No | No | Current |