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United States · US · US:54879-002_5115f4a9-63ad-ebc3-e063-6294a90a7ba8
Ethambutol Hydrochloride
Orange BookUNIISPLATC J04AK02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSTI Pharma LLC
CountryUS (United States)
ATC codeJ04AK02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
QE4VW5FO07
ETHAMBUTOL HYDROCHLORIDE
RxCUI 142435
Orange Book
N016320
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QE4VW5FO07",
"rxcui": "142435",
"inchikey": "AUAHHJJRFHRVPV-BZDVOYDHSA-N",
"display_name": "ETHAMBUTOL HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3f6428d6-3745-4337-ad78-ebfff9f49135": {
"match": "brand_token",
"title": "ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]",
"spl_version": "9",
"published_date": "2026-05-07"
}
},
"productid": "54879-002_5115f4a9-63ad-ebc3-e063-6294a90a7ba8",
"productndc": "54879-002",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "016320",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "500MG",
"product_no": "004",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ETHAMBUTOL HYDROCHLORIDE",
"proprietary_name": "Ethambutol Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "NDA016320",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Ethambutol Hydrochloride",
"start_marketing_date": "20061215",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code J04AK02.
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