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United States · US · US:0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c
Gentamicin Sulfate
Orange BookUNIISPLATC J01GB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01GB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1107130683151 TUBE in 1 CARTON (0713-0683-15) / 15 g in 1 TUBE
- ndc1107130683311 TUBE in 1 CARTON (0713-0683-31) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A064056
AT
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": "TOPICAL",
"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": "0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c",
"productndc": "0713-0683",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "064056",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "EQ 0.1% BASE",
"product_no": "001",
"approval_date": "Apr 29, 1994"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GENTAMICIN SULFATE",
"proprietary_name": "Gentamicin Sulfate",
"active_ingred_unit": "mg/g",
"application_number": "ANDA064056",
"marketing_category": "ANDA",
"nonproprietary_name": "Gentamicin Sulfate",
"start_marketing_date": "20161111",
"active_numerator_strength": "1"
}Related drugs
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