Mexiletine Hydrochloride
- Product NDC
- 33342-555
- 11-digit product format
- 333420555
- Labeler code
- 33342
- Product ID
- 33342-555_a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mexiletine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA219987
- Marketing category
- ANDA
- Marketing start
- 2026-03-23
- Substance
- MEXILETINE HYDROCHLORIDE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mexiletine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEXILETINE HYDROCHLORIDE | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 606D60IS38 |
| Rxcui | 1362706, 1362712 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-555-11 | Mexiletine Hydrochloride | 100 in 1 CONTAINER | CAPSULE | 100 | | 1 |
| 33342-555-12 | Mexiletine Hydrochloride | 10 in 1 CARTON | CAPSULE | 10 | | 1 |
| 33342-555-12 | Mexiletine Hydrochloride | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-555-11 | 33342055511 | 100 CAPSULE in 1 CONTAINER (33342-555-11) | 100 capsule | 2026-03-23 | No | No | Current |
| 33342-555-12 | 33342055512 | 10 BLISTER PACK in 1 CARTON (33342-555-12) / 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2026-03-23 | No | No | Current |