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United States · US · US:63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6
Amikacin Sulfate
Orange BookUNIISPLATC S01AA21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeS01AA21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633238150210 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)
- ndc11633238150410 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)
Annotations
UNII (FDA Substance ID)
N6M33094FD
AMIKACIN SULFATE
RxCUI 643
Orange Book
A205604
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": "63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6",
"productndc": "63323-815",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "205604",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/ML",
"product_no": "001",
"approval_date": "Dec 9, 2015"
}
],
"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": "ANDA205604",
"marketing_category": "ANDA",
"nonproprietary_name": "Amikacin Sulfate",
"start_marketing_date": "20151209",
"active_numerator_strength": "250"
}Related drugs
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- GBAmikacin 400micrograms/0.1ml intravitreal injection kitSpecial Order
- GBAmikacin 500mg/100ml infusion polyethylene bottlesFresenius Kabi Ltd
- GBAmikacin 500mg/2ml solution for injection ampoulesKent Pharma (UK) Ltd
- GBAmikacin 500mg/2ml solution for injection vialsTillomed Laboratories Ltd
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