Home NDC 23155-785 Amikacin Sulfate
Product NDC 23155-785
11-digit product format 231550785
Labeler code 23155
Product ID 23155-785_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 500 mg/2mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A204040-001 AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204040-001 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.
Product history page 1 of 2 · 41 observed 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 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204040-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP RS 2013-12-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amikacin Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMIKACIN SULFATE 500 mg/2mL
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 23155-785-31 Amikacin Sulfate 2 mL in 1 VIAL, GLASS INJECTION, SOLUTION 2 4 23155-785-41 Amikacin Sulfate 10 in 1 CARTON INJECTION, SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-785 AMIKACIN SULFATE INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230325_7791d3e1-9287-4f75-b4f0-e5d35cacfd6e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 23155-785-31 23155078531 2 mL in 1 VIAL, GLASS 2 ml Historical 23155-785-41 23155078541 10 VIAL, GLASS in 1 CARTON (23155-785-41) / 2 mL in 1 VIAL, GLASS (23155-785-31) 2020-12-15 0000-00-00 No No Current