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United States · US · US:45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5
Gentamicin Sulfate
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1145802046111 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBE
- ndc1145802046351 TUBE in 1 CARTON (45802-046-35) / 15 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A062351
AT
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": "TOPICAL",
"spl_meta": {
"977180b3-a222-4282-d485-4a3217674305": {
"match": "brand_token",
"title": "GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "22",
"published_date": "2026-05-22"
}
},
"productid": "45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5",
"productndc": "45802-046",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "062351",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AT",
"strength": "EQ 0.1% BASE",
"product_no": "001",
"approval_date": "Feb 18, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GENTAMICIN SULFATE",
"proprietary_name": "Gentamicin Sulfate",
"active_ingred_unit": "mg/g",
"application_number": "ANDA062351",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin Sulfate",
"start_marketing_date": "20060710",
"active_numerator_strength": "1"
}Related drugs
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