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United States · US · US:0404-9865_fa19ae2a-f30b-484f-b702-0e13b5431c33
Gentamicin Sulfate
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104049865021 VIAL, SINGLE-DOSE in 1 BAG (0404-9865-02) / 2 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A062420
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": "0404-9865_fa19ae2a-f30b-484f-b702-0e13b5431c33",
"productndc": "0404-9865",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "062420",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Aug 15, 1983"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 40MG BASE/ML",
"product_no": "002",
"approval_date": "Aug 15, 1983"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GENTAMICIN SULFATE",
"proprietary_name": "Gentamicin Sulfate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA062420",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin Sulfate",
"start_marketing_date": "20220110",
"active_numerator_strength": "40"
}Related drugs
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