Home NDC 50090-0251-0 Gentak
Product NDC 50090-0251
Requested package NDC 50090-0251-0
11-digit product format 500900251
Labeler code 50090
Product ID 50090-0251_b1f78fc0-3098-4984-8868-906962e4c36a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate
Dosage form OINTMENT
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application ANDA064093
Marketing category ANDA
Marketing start 2006-05-08
Marketing end 0000-00-00
Substance GENTAMICIN SULFATE
Active strength 3 mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A064093-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31
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 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gentak GENTAMICIN SULFATE Proficient Rx LP aebfe247-cdf7-4acb-97b3-6d4341d7c815 2019-11-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 064093 application number: ANDA064093
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-0251-0 50090025100 1 TUBE in 1 CARTON (50090-0251-0) > 3.5 g in 1 TUBE 1 tube 2016-06-29 0000-00-00 No No Current