amikacin sulfate

Generic: amikacin sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amikacin sulfate
Generic Name amikacin sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

amikacin sulfate 250 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-815
Product ID 63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205604
Listing Expiration 2026-12-31
Marketing Start 2015-12-09

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323815
Hyphenated Format 63323-815

Supplemental Identifiers

RxCUI
1723156 1723160
UPC
0363323815226
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 ANDA205604 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)
source: ndc

Packages (2)

63323-815-02 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21) 63323-815-04 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)

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": "04612f35-e6fb-4937-bdfe-32105876c5b6", "openfda": {"upc": ["0363323815226"], "unii": ["N6M33094FD"], "rxcui": ["1723156", "1723160"], "spl_set_id": ["c0f57839-1c9b-49e5-8c7a-708e2d16495d"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02)  / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21)", "package_ndc": "63323-815-02", "marketing_start_date": "20151209"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04)  / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22)", "package_ndc": "63323-815-04", "marketing_start_date": "20151209"}], "brand_name": "Amikacin Sulfate", "product_id": "63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-815", "generic_name": "Amikacin Sulfate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amikacin Sulfate", "active_ingredients": [{"name": "AMIKACIN SULFATE", "strength": "250 mg/mL"}], "application_number": "ANDA205604", "marketing_category": "ANDA", "marketing_start_date": "20151209", "listing_expiration_date": "20261231"}