Mexiletine Hydrochloride
- Product NDC
- 10135-730
- 11-digit product format
- 101350730
- Labeler code
- 10135
- Product ID
- 10135-730_d7dc41b7-6d65-1693-e053-2a95a90a70d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mexiletine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA213500
- Marketing category
- ANDA
- Marketing start
- 2022-02-01
- Marketing end
- 0000-00-00
- Substance
- MEXILETINE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-730-01 | 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 |
|---|
| 10135-730 | MEXILETINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS, INC.] | 2 | Legacy NDC, 1 package rows | 20231110_d7dc41b7-6d64-1693-e053-2a95a90a70d4.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 |
|---|
| 10135-730-01 | 10135073001 | 100 CAPSULE in 1 BOTTLE (10135-730-01) | 100 capsule | 2022-02-01 | 0000-00-00 | No | No | Current |