amikacin sulfate

Generic: amikacin sulfate

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amikacin sulfate
Generic Name amikacin sulfate
Labeler mullan pharmaceutical inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

amikacin sulfate 250 mg/mL

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0022
Product ID 83301-0022_4849a73e-8a94-e5c8-e063-6294a90acab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218146
Listing Expiration 2027-12-31
Marketing Start 2026-01-12

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 833010022
Hyphenated Format 83301-0022

Supplemental Identifiers

RxCUI
1723156 1723160
UPC
0383301002226 0383301002325
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, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1)
source: ndc

Packages (1)

83301-0022-2 10 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1)

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": "4849a73e-8a94-e5c8-e063-6294a90acab5", "openfda": {"upc": ["0383301002226", "0383301002325"], "unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["840ba25a-d60c-4f0d-a084-71b0c68237df"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2)  / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1)", "package_ndc": "83301-0022-2", "marketing_start_date": "20260112"}], "brand_name": "Amikacin Sulfate", "product_id": "83301-0022_4849a73e-8a94-e5c8-e063-6294a90acab5", "dosage_form": "INJECTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "83301-0022", "generic_name": "Amikacin Sulfate", "labeler_name": "Mullan Pharmaceutical Inc.", "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": "20260112", "listing_expiration_date": "20271231"}