Amikacin Sulfate Injection, 500 mg/2ml

Manufacturer: Safrel Pharmaceuticals, LLC.
Effective date: 2021-01-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:34:32

Label at a glance#

ProductAmikacin Sulfate Injection, 500 mg/2ml

Active ingredientAMIKACIN SULFATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

amikacin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1598047	amikacin 250 MG/ML Injectable Solution	SCD	1
1598047	amikacin (as amikacin sulfate) 250 MG/ML Injectable Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AMIKACIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e1d8d349-40e8-4ab6-9f36-aa84681732ed	Product name	3	20250124
7a2acf42-1a2f-4e31-9d74-f6d541e9bb46	Product name	1	20190111
37302fde-6a8c-4412-a7e0-b0fdb78cc567	Product name	1	20151215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71309-996-05	2023-01-30	C162847	48780-1	f386c649-dafa-0266-e053-dadaa90a7c1a	Amikacin Sulfate Injection, 500 mg / 2ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71309-996-05	Amikacin Sulfate Injection, 500 mg/2ml	500 in 1 VIAL	INJECTION	500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71309-996	AMIKACIN SULFATE INJECTION, 500 MG/2ML INJECTION [SAFREL PHARMACEUTICALS, LLC.]	1	1 package rows	20210107_b834ed2b-d0c5-6db3-e053-2995a90aa963.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Amikacin Sulfate Injection, 500 mg/2ml
SULFURIC ACID
SODIUM METABISULFITE
BISULFITE ION
SODIUM CITRATE
AMIKACIN SULFATE
AMIKACIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71309-996	71309-996-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SULFURIC ACID	O40UQP6WCF	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
AMIKACIN SULFATE	N6M33094FD	ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b834ed2b-d0c6-6db3-e053-2995a90aa963			b834ed2b-d0c5-6db3-e053-2995a90aa963	2021-01-03		Exact identifier spl id: b834ed2b-d0c6-6db3-e053-2995a90aa963 spl set id: b834ed2b-d0c5-6db3-e053-2995a90aa963

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.