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United States · US · US:0143-9128_9908273d-c700-4036-82fe-312f25a8aacd
Gentamicin
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014391282525 VIAL in 1 CARTON (0143-9128-25) / 2 mL in 1 VIAL (0143-9128-01)
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A062251
APAP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "0143-9128_9908273d-c700-4036-82fe-312f25a8aacd",
"productndc": "0143-9128",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "062251",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG BASE/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 10MG BASE/ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GENTAMICIN SULFATE",
"proprietary_name": "Gentamicin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA062251",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin",
"start_marketing_date": "20220215",
"active_numerator_strength": "40"
}Related drugs
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