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United States · US · US:0641-6166_36fb925f-8beb-4691-9136-500772c736fa
Amikacin Sulfate
Orange BookUNIISPLATC S01AA21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeS01AA21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064161661010 VIAL in 1 CARTON (0641-6166-10) / 4 mL in 1 VIAL (0641-6166-01)
Annotations
UNII (FDA Substance ID)
N6M33094FD
AMIKACIN SULFATE
RxCUI 643
Orange Book
A063315
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": "0641-6166_36fb925f-8beb-4691-9136-500772c736fa",
"productndc": "0641-6166",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "063315",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 250MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 11, 1994"
}
],
"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": "ANDA063315",
"marketing_category": "ANDA",
"nonproprietary_name": "Amikacin Sulfate",
"start_marketing_date": "20150801",
"active_numerator_strength": "250"
}Related drugs
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