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United States · US · US:63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b
Gentak
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163187873351 TUBE in 1 CARTON (63187-873-35) / 3.5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A064093
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8X7386QRLV",
"rxcui": "1870193",
"inchikey": null,
"display_name": "GENTAMICIN SULFATE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"1ab0eecf-5ce2-c2bc-e063-6394a90a744b": {
"match": "brand_token",
"title": "GENTAK (GENTAMICIN SULFATE) OINTMENT [REDPHARM DRUG]",
"spl_version": "1",
"published_date": "2024-06-13"
}
},
"productid": "63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b",
"productndc": "63187-873",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "064093",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.3% BASE",
"product_no": "001",
"approval_date": "Aug 31, 1995"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GENTAMICIN SULFATE",
"proprietary_name": "Gentak",
"active_ingred_unit": "mg/g",
"application_number": "ANDA064093",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin Sulfate",
"start_marketing_date": "20060508",
"active_numerator_strength": "3"
}Related drugs
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