amikacin sulfate

Generic: amikacin sulfate

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amikacin sulfate
Generic Name amikacin sulfate
Labeler qilu pharmaceutical co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

amikacin sulfate 250 mg/mL

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0569
Product ID 67184-0569_0a56f2df-a71f-44a1-b7d0-98ee44e30e80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218146
Listing Expiration 2026-12-31
Marketing Start 2024-03-19

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 671840569
Hyphenated Format 67184-0569

Supplemental Identifiers

RxCUI
1723156 1723160
UPC
0367184057016 0367184056910
UNII
N6M33094FD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amikacin sulfate (source: ndc)
Generic Name amikacin sulfate (source: ndc)
Application Number ANDA218146 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (67184-0569-2) / 2 mL in 1 VIAL, GLASS (67184-0569-1)
source: ndc

Packages (1)

67184-0569-2 10 VIAL, GLASS in 1 CARTON (67184-0569-2) / 2 mL in 1 VIAL, GLASS (67184-0569-1)

Ingredients (1)

amikacin sulfate (250 mg/mL)

Linked Drug Pages (1)

Amikacin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0a56f2df-a71f-44a1-b7d0-98ee44e30e80", "openfda": {"upc": ["0367184057016", "0367184056910"], "unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["20fa61ef-11e2-4d01-82ea-b5412cefaead"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (67184-0569-2)  / 2 mL in 1 VIAL, GLASS (67184-0569-1)", "package_ndc": "67184-0569-2", "marketing_start_date": "20240319"}], "brand_name": "Amikacin Sulfate", "product_id": "67184-0569_0a56f2df-a71f-44a1-b7d0-98ee44e30e80", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "67184-0569", "generic_name": "Amikacin Sulfate", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amikacin Sulfate", "active_ingredients": [{"name": "AMIKACIN SULFATE", "strength": "250 mg/mL"}], "application_number": "ANDA218146", "marketing_category": "ANDA", "marketing_start_date": "20240319", "listing_expiration_date": "20261231"}