Mexiletine hydrochloride
- Product NDC
- 31722-038
- 11-digit product format
- 317220038
- Labeler code
- 31722
- Product ID
- 31722-038_ed93311a-2bfc-3875-e053-2a95a90ac6f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mexiletine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA216463
- Marketing category
- ANDA
- Marketing start
- 2022-11-09
- 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 |
|---|
| 31722-038-01 | Mexiletine hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-038 | MEXILETINE HYDROCHLORIDE (MEXILETINE HYDROCHLORIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20221117_8b20e850-037b-4c16-a57d-c3d4909f147a.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 |
|---|
| 31722-038-01 | 31722003801 | 100 CAPSULE in 1 BOTTLE (31722-038-01) | 100 capsule | 2022-11-09 | 0000-00-00 | No | No | Current |