Amikacin Sulfate

Product NDC
23155-290
11-digit product format
231550290
Labeler code
23155
Product ID
23155-290_2c6edc4f-e89f-42ad-bb94-0ae9e4cd8838
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amikacin Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204040
Marketing category
ANDA
Marketing start
2013-12-24
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
23155-290-31Amikacin Sulfate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION220
23155-290-32Amikacin Sulfate4 mL in 1 VIAL, GLASSINJECTION, SOLUTION420
23155-290-41Amikacin Sulfate10 in 1 CARTONINJECTION, SOLUTION1020
23155-290-42Amikacin Sulfate10 in 1 CARTONINJECTION, SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-290-31ML - Milliliter23155-290ac25f272-a39d-4995-b6c7-a3067c2be47b12014-04-03
23155-290-32ML - Milliliter23155-290b2ebd862-d615-41ff-b41b-c96182e507e612014-04-03
23155-290-41ML - Milliliter23155-290af5e2ca6-6755-4956-bcfc-ffee08f59eb912014-04-03
23155-290-42ML - Milliliter23155-29089954f90-4463-4339-9413-3267b57384a012014-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-290AMIKACIN SULFATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 4 package rows20240619_a43188fa-f228-4acd-8a5d-9a3462034f4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723160amikacin sulfate 1 GM in 4 ML InjectionPSNa43188fa-f228-4acd-8a5d-9a3462034f4b20
1723156amikacin sulfate 500 MG in 2 ML InjectionPSNa43188fa-f228-4acd-8a5d-9a3462034f4b20
17231562 ML amikacin 250 MG/ML InjectionSCDa43188fa-f228-4acd-8a5d-9a3462034f4b20
17231604 ML amikacin 250 MG/ML InjectionSCDa43188fa-f228-4acd-8a5d-9a3462034f4b20
1723160amikacin (as amikacin sulfate) 1 GM per 4 ML InjectionSYa43188fa-f228-4acd-8a5d-9a3462034f4b20
1723156amikacin (as amikacin sulfate) 500 MG per 2 ML InjectionSYa43188fa-f228-4acd-8a5d-9a3462034f4b20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-290-31231550290312 mL in 1 VIAL, GLASS2 mlHistorical
23155-290-32231550290324 mL in 1 VIAL, GLASS4 mlHistorical
23155-290-412315502904110 VIAL, GLASS in 1 CARTON (23155-290-41) / 2 mL in 1 VIAL, GLASS (23155-290-31) 2013-12-240000-00-00NoNoCurrent
23155-290-422315502904210 VIAL, GLASS in 1 CARTON (23155-290-42) / 4 mL in 1 VIAL, GLASS (23155-290-32) 2013-12-240000-00-00NoNoCurrent