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United States · US · US:23155-785_7f946330-e4c6-4643-903d-3695d08df7d6
Amikacin Sulfate
Orange BookUNIISPLATC S01AA21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01AA21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11231557854110 VIAL, GLASS in 1 CARTON (23155-785-41) / 2 mL in 1 VIAL, GLASS (23155-785-31)
Annotations
UNII (FDA Substance ID)
N6M33094FD
AMIKACIN SULFATE
RxCUI 643
Orange Book
A204040
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N6M33094FD",
"rxcui": "643",
"inchikey": "FXKSEJFHKVNEFI-GCZBSULCSA-N",
"display_name": "AMIKACIN SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"840ba25a-d60c-4f0d-a084-71b0c68237df": {
"match": "brand_token",
"title": "AMIKACIN SULFATE INJECTION [MULLAN PHARMACEUTICAL INC.]",
"spl_version": "2",
"published_date": "2026-01-14"
}
},
"productid": "23155-785_7f946330-e4c6-4643-903d-3695d08df7d6",
"productndc": "23155-785",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "204040",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/ML",
"product_no": "001",
"approval_date": "Dec 12, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIKACIN SULFATE",
"proprietary_name": "Amikacin Sulfate",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA204040",
"marketing_category": "ANDA",
"nonproprietary_name": "Amikacin Sulfate",
"start_marketing_date": "20201215",
"active_numerator_strength": "500"
}Related drugs
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