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United States · US · US:55150-403_c72dacd5-33b4-456e-ad96-0e8635a73854
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
- ndc11551504032525 VIAL, MULTI-DOSE in 1 CARTON (55150-403-25) / 20 mL in 1 VIAL, MULTI-DOSE (55150-403-01)
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A215237
AP
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": "55150-403_c72dacd5-33b4-456e-ad96-0e8635a73854",
"productndc": "55150-403",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "215237",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG 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": "ANDA215237",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin",
"start_marketing_date": "20240108",
"active_numerator_strength": "40"
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