FDA.reportPublic FDA data

Amikacin Sulfate

Product NDC
23155-786
11-digit product format
231550786
Labeler code
23155
Product ID
23155-786_7f946330-e4c6-4643-903d-3695d08df7d6
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
2020-12-15
Substance
AMIKACIN SULFATE
Active strength
1 g/4mL
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 SULFATE1 g/4mL

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-786-31Amikacin Sulfate4 mL in 1 VIAL, GLASSINJECTION, SOLUTION44
23155-786-41Amikacin Sulfate10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-786-31ML - Milliliter23155-786723505b8-d1e8-4ce6-bbe8-ebddc62bd85912021-04-08
23155-786-41ML - Milliliter23155-7863775605c-099b-4f78-9bad-df2d95c2492312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-786AMIKACIN SULFATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20230325_7791d3e1-9287-4f75-b4f0-e5d35cacfd6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723160amikacin sulfate 1 GM in 4 ML InjectionPSN7791d3e1-9287-4f75-b4f0-e5d35cacfd6e4
1723156amikacin sulfate 500 MG in 2 ML InjectionPSN7791d3e1-9287-4f75-b4f0-e5d35cacfd6e4
17231562 ML amikacin 250 MG/ML InjectionSCD7791d3e1-9287-4f75-b4f0-e5d35cacfd6e4
17231604 ML amikacin 250 MG/ML InjectionSCD7791d3e1-9287-4f75-b4f0-e5d35cacfd6e4
1723160amikacin (as amikacin sulfate) 1 GM per 4 ML InjectionSY7791d3e1-9287-4f75-b4f0-e5d35cacfd6e4
1723156amikacin (as amikacin sulfate) 500 MG per 2 ML InjectionSY7791d3e1-9287-4f75-b4f0-e5d35cacfd6e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-786-31231550786314 mL in 1 VIAL, GLASS4 mlHistorical
23155-786-412315507864110 VIAL, GLASS in 1 CARTON (23155-786-41) / 4 mL in 1 VIAL, GLASS (23155-786-31) 2020-12-150000-00-00NoNoCurrent