🇺🇸
United States · US · US:63323-173_9f48c9f7-08fd-4652-911c-c2c221a34ed3
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 · 1
- ndc11633231739525 VIAL in 1 TRAY (63323-173-95) / 2 mL in 1 VIAL
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": "63323-173_9f48c9f7-08fd-4652-911c-c2c221a34ed3",
"productndc": "63323-173",
"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",
"start_marketing_date": "20041129",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J01GB03.
- GBCidomycin 80mg/2ml solution for injection ampoulesAdvanz Pharma
- GBCidomycin 80mg/2ml solution for injection vialsAdvanz Pharma
- GBCidomycin Intrathecal 5mg/1ml solution for injection ampoulesAventis Pharma
- GBCidomycin Paediatric 20mg/2ml solution for injection vialsBeacon Pharmaceuticals Ltd
- BEDuracoll 130 mgSERB
- BEDuracoll 32.5 mgSERB
- FIG-MycinOrion Corporation Orion Pharma
- FIG-MycinOrion Corporation Orion Pharma
Access this data programmatically
Query Gentamicin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.