amikacin sulfate

Generic: amikacin sulfate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amikacin sulfate
Generic Name amikacin sulfate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

amikacin sulfate 250 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-173
Product ID 25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203323
Listing Expiration 2026-12-31
Marketing Start 2016-06-15

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021173
Hyphenated Format 25021-173

Supplemental Identifiers

RxCUI
1723156 1723160
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 ANDA203323 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-173-02) / 2 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-173-04) / 4 mL in 1 VIAL
source: ndc

Packages (2)

25021-173-02 10 VIAL in 1 CARTON (25021-173-02) / 2 mL in 1 VIAL 25021-173-04 10 VIAL in 1 CARTON (25021-173-04) / 4 mL in 1 VIAL

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": "628539d5-fc0d-44a8-a854-b1e78382e78d", "openfda": {"unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["f260ff2a-76a0-4672-9516-91c344b67890"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-173-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-173-02", "marketing_start_date": "20160615"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-173-04)  / 4 mL in 1 VIAL", "package_ndc": "25021-173-04", "marketing_start_date": "20160615"}], "brand_name": "amikacin sulfate", "product_id": "25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "25021-173", "generic_name": "amikacin sulfate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amikacin sulfate", "active_ingredients": [{"name": "AMIKACIN SULFATE", "strength": "250 mg/mL"}], "application_number": "ANDA203323", "marketing_category": "ANDA", "marketing_start_date": "20160615", "listing_expiration_date": "20261231"}