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 1 g/4mL

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

Identifiers & Regulatory

Product NDC 23155-786
Product ID 23155-786_7f946330-e4c6-4643-903d-3695d08df7d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204040
Listing Expiration 2026-12-31
Marketing Start 2020-12-15

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155786
Hyphenated Format 23155-786

Supplemental Identifiers

RxCUI
1723156 1723160
UPC
0323155786316 0323155785319
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
  • 1 g/4mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (23155-786-41) / 4 mL in 1 VIAL, GLASS (23155-786-31)
source: ndc

Packages (1)

Ingredients (1)

amikacin sulfate (1 g/4mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "7f946330-e4c6-4643-903d-3695d08df7d6", "openfda": {"upc": ["0323155786316", "0323155785319"], "unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["7791d3e1-9287-4f75-b4f0-e5d35cacfd6e"], "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 (23155-786-41)  / 4 mL in 1 VIAL, GLASS (23155-786-31)", "package_ndc": "23155-786-41", "marketing_start_date": "20201215"}], "brand_name": "Amikacin Sulfate", "product_id": "23155-786_7f946330-e4c6-4643-903d-3695d08df7d6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "23155-786", "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": "1 g/4mL"}], "application_number": "ANDA204040", "marketing_category": "ANDA", "marketing_start_date": "20201215", "listing_expiration_date": "20261231"}