MEXILETINE HYDROCHLORIDE
- Product NDC
- 62135-785
- 11-digit product format
- 621350785
- Labeler code
- 62135
- Product ID
- 62135-785_462a5c01-c4ca-6bfa-e063-6294a90a4dd9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mexiletine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA213500
- Marketing category
- ANDA
- Marketing start
- 2020-07-23
- Substance
- MEXILETINE HYDROCHLORIDE
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 606D60IS38 |
| Rxcui | 1362720 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-785-90 | MEXILETINE HYDROCHLORIDE | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-785 | MEXILETINE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241025_4e03e02f-c516-479e-9126-86b0df7f8b1c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-785-90 | 62135078590 | 90 CAPSULE in 1 BOTTLE (62135-785-90) | 90 capsule | 2023-10-25 | No | No | Historical |