Home NDC 83301-0022-2 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218146-001 AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218146-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218146-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2024-03-19 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Amikacin Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIKACIN SULFATE 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N6M33094FD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1723156 Internal RxNorm lookup 1723160 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83301-0022-1 Amikacin Sulfate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 2 83301-0022-2 Amikacin Sulfate 10 in 1 CARTON INJECTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83301-0022 AMIKACIN SULFATE INJECTION [MULLAN PHARMACEUTICAL INC.] 1 Current NDC, 2 package rows 20250426_840ba25a-d60c-4f0d-a084-71b0c68237df.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83301-0022-2 83301002202 10 VIAL, SINGLE-DOSE in 1 CARTON (83301-0022-2) / 2 mL in 1 VIAL, SINGLE-DOSE (83301-0022-1) 2026-01-12 No No Current