Back to search
🇺🇸

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

  • ndc11
    2315578541
    10 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

Other records sharing ATC code S01AA21.

Access this data programmatically

Query Amikacin Sulfate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.