FDA.reportPublic FDA data

Amikacin Sulfate

Product NDC
63323-815
11-digit product format
633230815
Labeler code
63323
Product ID
63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amikacin Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA205604
Marketing category
ANDA
Marketing start
2015-12-09
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
63323-815-02Amikacin Sulfate10 in 1 CARTONINJECTION, SOLUTION108
63323-815-04Amikacin Sulfate10 in 1 CARTONINJECTION, SOLUTION108
63323-815-21Amikacin Sulfate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION28
63323-815-22Amikacin Sulfate4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-815-02ML - Milliliter63323-8155166e274-ada9-427a-9351-5a2df504cdb312016-04-04
63323-815-04ML - Milliliter63323-81508e3da9b-0d25-4f22-ac6e-0660b48ae78d12016-04-04
63323-815-21ML - Milliliter63323-81595ca14c7-6621-405a-a3be-17b71e0bc2bc12019-08-06
63323-815-22ML - Milliliter63323-81562ccccbe-43db-4c54-9eb2-1e6ea12054e012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-815AMIKACIN SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 4 package rows20230707_c0f57839-1c9b-49e5-8c7a-708e2d16495d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723160amikacin sulfate 1 GM in 4 ML InjectionPSNc0f57839-1c9b-49e5-8c7a-708e2d16495d8
1723156amikacin sulfate 500 MG in 2 ML InjectionPSNc0f57839-1c9b-49e5-8c7a-708e2d16495d8
17231562 ML amikacin 250 MG/ML InjectionSCDc0f57839-1c9b-49e5-8c7a-708e2d16495d8
17231604 ML amikacin 250 MG/ML InjectionSCDc0f57839-1c9b-49e5-8c7a-708e2d16495d8
1723160amikacin (as amikacin sulfate) 1 GM per 4 ML InjectionSYc0f57839-1c9b-49e5-8c7a-708e2d16495d8
1723156amikacin (as amikacin sulfate) 500 MG per 2 ML InjectionSYc0f57839-1c9b-49e5-8c7a-708e2d16495d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-815-026332308150210 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-815-21) 2015-12-090000-00-00NoNoCurrent
63323-815-046332308150410 VIAL, SINGLE-DOSE in 1 CARTON (63323-815-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-815-22) 2015-12-090000-00-00NoNoCurrent
63323-815-21633230815212 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-815-22633230815224 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical