MEXILETINE HYDROCHLORIDE
- Product NDC
- 62756-957
- 11-digit product format
- 627560957
- Labeler code
- 62756
- Product ID
- 62756-957_7bb96934-8c07-463e-b96e-cafaafb8d2dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mexiletine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA214089
- Marketing category
- ANDA
- Marketing start
- 2021-11-29
- 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 | 1362706, 1362712, 1362720 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-957-01 | MEXILETINE HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-957 | MEXILETINE HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230428_2d0c61ca-4c99-42f9-8f00-e0e9d2672a39.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 |
|---|
| 62756-957-01 | 62756095701 | 100 CAPSULE in 1 BOTTLE (62756-957-01) | 100 capsule | 2021-11-29 | 0000-00-00 | No | No | Current |