FDA.reportPublic FDA data

Amikacin Sulfate

Product NDC
0641-6166
11-digit product format
006416166
Labeler code
0641
Product ID
0641-6166_36fb925f-8beb-4691-9136-500772c736fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amikacin Sulfate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA063315
Marketing category
ANDA
Marketing start
2015-08-01
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6166-01Amikacin Sulfate4 mL in 1 VIALINJECTION410
0641-6166-10Amikacin Sulfate10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6166-01ML - Milliliter0641-61663cfe97bf-23bc-48b5-82f2-8afece928a1612016-01-13
0641-6166-10ML - Milliliter0641-61663b98a712-a6ff-48bd-bc4f-95d6ae0cc65a12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIKACIN SULFATEACTIVE INGREDIENTN6M33094FDAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
AMIKACINACTIVE MOIETY84319SGC3CAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM CITRATE, UNSPECIFIED FORMINACTIVE INGREDIENT1Q73Q2JULRAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RAMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6166AMIKACIN SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240410_0b56f6df-a05d-4520-8bf0-d7cefe20f6ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723160amikacin sulfate 1 GM in 4 ML InjectionPSN0b56f6df-a05d-4520-8bf0-d7cefe20f6ad10
1723156amikacin sulfate 500 MG in 2 ML InjectionPSN0b56f6df-a05d-4520-8bf0-d7cefe20f6ad10
17231562 ML amikacin 250 MG/ML InjectionSCD0b56f6df-a05d-4520-8bf0-d7cefe20f6ad10
17231604 ML amikacin 250 MG/ML InjectionSCD0b56f6df-a05d-4520-8bf0-d7cefe20f6ad10
1723160amikacin (as amikacin sulfate) 1 GM per 4 ML InjectionSY0b56f6df-a05d-4520-8bf0-d7cefe20f6ad10
1723156amikacin (as amikacin sulfate) 500 MG per 2 ML InjectionSY0b56f6df-a05d-4520-8bf0-d7cefe20f6ad10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6166-01006416166014 mL in 1 VIAL4 mlHistorical
0641-6166-100064161661010 VIAL in 1 CARTON (0641-6166-10) / 4 mL in 1 VIAL (0641-6166-01) 10 vial2015-08-010000-00-00NoNoCurrent