amikacin sulfate

Generic: amikacin sulfate

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amikacin sulfate
Generic Name amikacin sulfate
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

amikacin sulfate 250 mg/mL

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-290
Product ID 23155-290_2c6edc4f-e89f-42ad-bb94-0ae9e4cd8838
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204040
Listing Expiration 2026-12-31
Marketing Start 2013-12-24

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155290
Hyphenated Format 23155-290

Supplemental Identifiers

RxCUI
1723156 1723160
UPC
0323155290325 0323155290318
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 ANDA204040 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (23155-290-41) / 2 mL in 1 VIAL, GLASS (23155-290-31)
  • 10 VIAL, GLASS in 1 CARTON (23155-290-42) / 4 mL in 1 VIAL, GLASS (23155-290-32)
source: ndc

Packages (2)

23155-290-41 10 VIAL, GLASS in 1 CARTON (23155-290-41) / 2 mL in 1 VIAL, GLASS (23155-290-31) 23155-290-42 10 VIAL, GLASS in 1 CARTON (23155-290-42) / 4 mL in 1 VIAL, GLASS (23155-290-32)

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": "2c6edc4f-e89f-42ad-bb94-0ae9e4cd8838", "openfda": {"upc": ["0323155290325", "0323155290318"], "unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["a43188fa-f228-4acd-8a5d-9a3462034f4b"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (23155-290-41)  / 2 mL in 1 VIAL, GLASS (23155-290-31)", "package_ndc": "23155-290-41", "marketing_start_date": "20131224"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (23155-290-42)  / 4 mL in 1 VIAL, GLASS (23155-290-32)", "package_ndc": "23155-290-42", "marketing_start_date": "20131224"}], "brand_name": "Amikacin Sulfate", "product_id": "23155-290_2c6edc4f-e89f-42ad-bb94-0ae9e4cd8838", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "23155-290", "generic_name": "Amikacin Sulfate", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amikacin Sulfate", "active_ingredients": [{"name": "AMIKACIN SULFATE", "strength": "250 mg/mL"}], "application_number": "ANDA204040", "marketing_category": "ANDA", "marketing_start_date": "20131224", "listing_expiration_date": "20261231"}