Amikacin Sulfate

Product NDC
83301-0022
Requested package NDC
83301-0022-2
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218146-001AMIKACIN SULFATEAMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218146-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-198072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218146-001AMIKACIN SULFATEEQ 250MG BASE/MLINJECTABLE / INJECTIONAP2024-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218146-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218146-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218146-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218146-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218146-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218146-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218146-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218146-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218146-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218146-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218146-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218146-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218146-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218146-001AP18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218146-001AP1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N6M33094FDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1723156Internal RxNorm lookup
1723160Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
840ba25a-d60c-4f0d-a084-71b0c68237dfAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amikacin SulfateAMIKACIN SULFATEMullan Pharmaceutical Inc.840ba25a-d60c-4f0d-a084-71b0c68237df2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218146
application number: ANDA218146
ndc (package): 83301-0022-2
ndc (product): 83301-0022
ndc11 (package): 83301002202
Amikacin SulfateAMIKACIN SULFATEQilu Pharmaceutical Co., Ltd.20fa61ef-11e2-4d01-82ea-b5412cefaead2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218146
application number: ANDA218146

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 formatDescriptionMarketing startSampleExclude flagStatus
83301-0022-28330100220210 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1) 2026-01-12NoNoCurrent