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United States · US · US:63323-010_cf4327d0-9155-4a07-9c54-51592b66b817
Gentamicin
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633230100225 VIAL in 1 TRAY (63323-010-02) / 2 mL in 1 VIAL (63323-010-01)
- ndc11633230102025 VIAL in 1 TRAY (63323-010-20) / 20 mL in 1 VIAL (63323-010-03)
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A062366
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": "63323-010_cf4327d0-9155-4a07-9c54-51592b66b817",
"productndc": "63323-010",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "062366",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG BASE/ML",
"product_no": "001",
"approval_date": "Aug 4, 1983"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 10MG BASE/ML",
"product_no": "002",
"approval_date": "Feb 6, 1986"
}
],
"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": "ANDA062366",
"marketing_category": "ANDA",
"nonproprietary_name": "GENTAMICIN SULFATE",
"start_marketing_date": "20000810",
"active_numerator_strength": "40"
}Related drugs
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