FDA.reportPublic FDA data

Amikacin Sulfate

Product NDC
83301-0022
11-digit product format
833010022
Labeler code
83301
Product ID
83301-0022_4849a73e-8a94-e5c8-e063-6294a90acab5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amikacin Sulfate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA218146
Marketing category
ANDA
Marketing start
2026-01-12
Substance
AMIKACIN SULFATE
Active strength
250 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amikacin Sulfate
Listing expiration
2027-12-31

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
83301-0022-1Amikacin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION22
83301-0022-2Amikacin Sulfate10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0022-1ML - Milliliter83301-00226e07d502-a1ee-4023-a9ad-3bbb7f2c99b312026-02-05
83301-0022-2ML - Milliliter83301-0022729c72ae-6fa0-45f5-bddc-6a5a8d0991a412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0022AMIKACIN SULFATE INJECTION [MULLAN PHARMACEUTICAL INC.]1Current NDC, 2 package rows20250426_840ba25a-d60c-4f0d-a084-71b0c68237df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723160amikacin sulfate 1 GM in 4 ML InjectionPSN840ba25a-d60c-4f0d-a084-71b0c68237df2
1723156amikacin sulfate 500 MG in 2 ML InjectionPSN840ba25a-d60c-4f0d-a084-71b0c68237df2
17231562 ML amikacin 250 MG/ML InjectionSCD840ba25a-d60c-4f0d-a084-71b0c68237df2
17231604 ML amikacin 250 MG/ML InjectionSCD840ba25a-d60c-4f0d-a084-71b0c68237df2
1723160amikacin (as amikacin sulfate) 1 GM per 4 ML InjectionSY840ba25a-d60c-4f0d-a084-71b0c68237df2
1723156amikacin (as amikacin sulfate) 500 MG per 2 ML InjectionSY840ba25a-d60c-4f0d-a084-71b0c68237df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83301-0022-1833010022012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
83301-0022-28330100220210 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1) 2026-01-12NoNoHistorical