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United States · US · US:68071-4827_1ade255c-bb1d-b03f-e063-6294a90a6d78
GENTAMICIN SULFATE
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168071482755 mL in 1 BOX (68071-4827-5)
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A062452
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": {
"977180b3-a222-4282-d485-4a3217674305": {
"match": "brand_token",
"title": "GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "22",
"published_date": "2026-05-22"
}
},
"productid": "68071-4827_1ade255c-bb1d-b03f-e063-6294a90a6d78",
"productndc": "68071-4827",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "062452",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 0.3% BASE",
"product_no": "001",
"approval_date": "Oct 10, 1984"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GENTAMICIN SULFATE",
"proprietary_name": "GENTAMICIN SULFATE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA062452",
"marketing_category": "ANDA",
"nonproprietary_name": "gentamicin sulfate",
"start_marketing_date": "19980105",
"active_numerator_strength": "3"
}Related drugs
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