Gentamicin Sulfate

Product NDC
50090-0249
11-digit product format
500900249
Labeler code
50090
Product ID
50090-0249_809995b9-aa39-4559-9fe8-4ed7a65e71da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA064048
Marketing category
ANDA
Marketing start
1994-05-11
Marketing end
0000-00-00
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0249DDiscontinued by firm2026-08-03
excluded packagepackage50090-024950090-0249-0DDiscontinued by firm2026-08-03

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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0249-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0249-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0249-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0249-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0249-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0249-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0249-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0249-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0249-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0249-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0249-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0249-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50090-0249-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064048-001GENTAMICIN SULFATEGENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064048-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-113f01610625f2…
2019-09-15 20:21 UTC2019-09A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064048-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT1994-05-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064048-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064048-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064048-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064048-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064048-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064048-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064048-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064048-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064048-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064048-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064048-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064048-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064048-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064048-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064048-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064048-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064048-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064048-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064048-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064048-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064048-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064048-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064048-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064048-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064048-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064048-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064048-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064048-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064048-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064048-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064048-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064048-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064048-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064048-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064048-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064048-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064048-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064048-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064048-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064048-001AT1cb3db0bc1861…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048
Gentamicin Sulfate Opth SolutionGENTAMICIN SULFATE OPTH SOLUTIONDirect_Rxe1a5bc32-f9a0-6b33-e053-2995a90ab9ac2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048
Gentamicin SulfateGENTAMICIN SULFATEA-S Medication Solutions76fabcd6-4da3-49e3-85a1-ca4fac55a2072023-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048
Gentamicin SulfateGENTAMICIN SULFATEAsclemed USA, Inc.b59e49e0-640b-43c3-ad07-711d1bb154e92022-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP3a6677a6-def5-443e-82bc-c185d41f03b72022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064048
application number: ANDA064048