amikacin sulfate

Generic: amikacin sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amikacin sulfate
Generic Name amikacin sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

amikacin sulfate 250 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6166
Product ID 0641-6166_36fb925f-8beb-4691-9136-500772c736fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063315
Listing Expiration 2026-12-31
Marketing Start 2015-08-01

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416166
Hyphenated Format 0641-6166

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 ANDA063315 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6166-10) / 4 mL in 1 VIAL (0641-6166-01)
source: ndc

Packages (1)

0641-6166-10 10 VIAL in 1 CARTON (0641-6166-10) / 4 mL in 1 VIAL (0641-6166-01)

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": "36fb925f-8beb-4691-9136-500772c736fa", "openfda": {"unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["0b56f6df-a05d-4520-8bf0-d7cefe20f6ad"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6166-10)  / 4 mL in 1 VIAL (0641-6166-01)", "package_ndc": "0641-6166-10", "marketing_start_date": "20150801"}], "brand_name": "Amikacin Sulfate", "product_id": "0641-6166_36fb925f-8beb-4691-9136-500772c736fa", "dosage_form": "INJECTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0641-6166", "generic_name": "Amikacin Sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amikacin Sulfate", "active_ingredients": [{"name": "AMIKACIN SULFATE", "strength": "250 mg/mL"}], "application_number": "ANDA063315", "marketing_category": "ANDA", "marketing_start_date": "20150801", "listing_expiration_date": "20261231"}