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United States · US · US:25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d
amikacin sulfate
Orange BookUNIISPLATC S01AA21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeS01AA21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11250211730210 VIAL in 1 CARTON (25021-173-02) / 2 mL in 1 VIAL
- ndc11250211730410 VIAL in 1 CARTON (25021-173-04) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
N6M33094FD
AMIKACIN SULFATE
RxCUI 643
Orange Book
A203323
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": "25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d",
"productndc": "25021-173",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "203323",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/ML",
"product_no": "001",
"approval_date": "May 12, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIKACIN SULFATE",
"proprietary_name": "amikacin sulfate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203323",
"marketing_category": "ANDA",
"nonproprietary_name": "amikacin sulfate",
"start_marketing_date": "20160615",
"active_numerator_strength": "250"
}Related drugs
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