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United States · US · US:55150-401_ec7eac4d-564f-4f16-b90a-a0c54d403056
Gentamicin
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551504012525 VIAL, SINGLE-DOSE in 1 CARTON (55150-401-25) / 2 mL in 1 VIAL, SINGLE-DOSE (55150-401-01)
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A215236
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": "55150-401_ec7eac4d-564f-4f16-b90a-a0c54d403056",
"productndc": "55150-401",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "215236",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Jan 8, 2024"
}
],
"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": "ANDA215236",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin",
"start_marketing_date": "20240108",
"active_numerator_strength": "10"
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