Home NDC 53217-229 Gentamicin Sulfate
Product NDC 53217-229
11-digit product format 532170229
Labeler code 53217
Product ID 53217-229_a65eb341-e2eb-43fc-94e5-b0b995459f57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Aidarex Pharmaceuticals LLC
Application ANDA064163
Marketing category ANDA
Marketing start 2006-12-13
Marketing end 0000-00-00
Substance GENTAMICIN SULFATE
Active strength 3 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53217-229-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53217-229-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53217-229-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53217-229-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53217-229-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53217-229-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53217-229-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53217-229-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53217-229-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53217-229-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53217-229-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53217-229-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53217-229-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53217-229-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53217-229-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53217-229-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53217-229-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53217-229-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53217-229-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53217-229-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53217-229-01 9bebd1f3094a…5416666fcb17…
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 A064163-001 GENTAK GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12
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 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53217-229-01 Gentamicin Sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 1 53217-229-01 Gentamicin Sulfate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53217-229 GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 2 package rows 20170220_32c24dd7-11d4-420a-afee-a6e37baa4d0f.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 Status 53217-229-01 53217022901 1 in 1 CARTON Historical