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United States · US · US:0093-8741_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9
Mexiletine Hydrochloride
Orange BookUNIISPLATC C01BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC01BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110093874101100 CAPSULE in 1 BOTTLE (0093-8741-01)
Annotations
UNII (FDA Substance ID)
606D60IS38
MEXILETINE HYDROCHLORIDE
RxCUI 142138
Orange Book
A074377
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "606D60IS38",
"rxcui": "142138",
"inchikey": "NFEIBWMZVIVJLQ-UHFFFAOYSA-N",
"display_name": "MEXILETINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1": {
"match": "brand_token",
"title": "MEXILETINE HYDROCHLORIDE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]",
"spl_version": "1",
"published_date": "2026-04-17"
}
},
"productid": "0093-8741_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9",
"productndc": "0093-8741",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "074377",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "May 16, 1995"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "002",
"approval_date": "May 16, 1995"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "250MG",
"product_no": "003",
"approval_date": "May 16, 1995"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEXILETINE HYDROCHLORIDE",
"proprietary_name": "Mexiletine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA074377",
"marketing_category": "ANDA",
"nonproprietary_name": "Mexiletine Hydrochloride",
"start_marketing_date": "19950605",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code C01BB02.
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