Mexiletine Hydrochloride
- Product NDC
- 0527-4108
- 11-digit product format
- 005274108
- Labeler code
- 0527
- Product ID
- 0527-4108_8da7d3ff-0e0c-4401-8ced-81bbc16c230b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mexiletine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA213500
- Marketing category
- ANDA
- Marketing start
- 2020-07-23
- 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 |
|---|
| 0527-4108-37 | Mexiletine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-4108 | MEXILETINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230111_4cf19b14-050e-4083-8f1e-6618310e02f1.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 |
|---|
| 0527-4108-37 | 00527410837 | 100 CAPSULE in 1 BOTTLE (0527-4108-37) | 100 capsule | 2020-07-23 | 0000-00-00 | No | No | Current |