FDA.reportPublic FDA data

amikacin sulfate

Product NDC
25021-173
11-digit product format
250210173
Labeler code
25021
Product ID
25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amikacin sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA203323
Marketing category
ANDA
Marketing start
2016-06-15
Substance
AMIKACIN SULFATE
Active strength
250 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
amikacin sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIKACIN SULFATE250 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6M33094FD
Rxcui1723156, 1723160

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e1d8d349-40e8-4ab6-9f36-aa84681732edProduct name320250124
7a2acf42-1a2f-4e31-9d74-f6d541e9bb46Product name120190111
37302fde-6a8c-4412-a7e0-b0fdb78cc567Product name120151215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-173-02amikacin sulfate10 in 1 CARTONINJECTION, SOLUTION109
25021-173-02amikacin sulfate2 mL in 1 VIALINJECTION, SOLUTION29
25021-173-04amikacin sulfate4 mL in 1 VIALINJECTION, SOLUTION49
25021-173-04amikacin sulfate10 in 1 CARTONINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-173-02ML - Milliliter25021-173dbcd44d9-5fe3-4e1e-ab89-4aa052b3538712016-07-19
25021-173-04ML - Milliliter25021-173e8d67d9d-113a-47f8-8082-baa613cbe27612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-173AMIKACIN SULFATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20221110_f260ff2a-76a0-4672-9516-91c344b67890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723160amikacin sulfate 1 GM in 4 ML InjectionPSNf260ff2a-76a0-4672-9516-91c344b678909
1723156amikacin sulfate 500 MG in 2 ML InjectionPSNf260ff2a-76a0-4672-9516-91c344b678909
17231562 ML amikacin 250 MG/ML InjectionSCDf260ff2a-76a0-4672-9516-91c344b678909
17231604 ML amikacin 250 MG/ML InjectionSCDf260ff2a-76a0-4672-9516-91c344b678909
1723160amikacin (as amikacin sulfate) 1 GM per 4 ML InjectionSYf260ff2a-76a0-4672-9516-91c344b678909
1723156amikacin (as amikacin sulfate) 500 MG per 2 ML InjectionSYf260ff2a-76a0-4672-9516-91c344b678909

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-173-022502101730210 VIAL in 1 CARTON (25021-173-02) / 2 mL in 1 VIAL10 vial2016-06-150000-00-00NoNoCurrent
25021-173-042502101730410 VIAL in 1 CARTON (25021-173-04) / 4 mL in 1 VIAL10 vial2016-06-150000-00-00NoNoCurrent