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United States · US · US:83301-0022_4849a73e-8a94-e5c8-e063-6294a90acab5
Amikacin Sulfate
Orange BookUNIISPLATC S01AA21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMullan Pharmaceutical Inc.
CountryUS (United States)
ATC codeS01AA21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11833010022210 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1)
Annotations
UNII (FDA Substance ID)
N6M33094FD
AMIKACIN SULFATE
RxCUI 643
Orange Book
A218146
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": "83301-0022_4849a73e-8a94-e5c8-e063-6294a90acab5",
"productndc": "83301-0022",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218146",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/ML",
"product_no": "001",
"approval_date": "Mar 19, 2024"
}
],
"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": "ANDA218146",
"marketing_category": "ANDA",
"nonproprietary_name": "Amikacin Sulfate",
"start_marketing_date": "20260112",
"active_numerator_strength": "250"
}Related drugs
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