Gentamicin Sulfate

Product NDC
53002-9291
11-digit product format
530029291
Labeler code
53002
Product ID
53002-9291_46507b73-1131-479b-9a42-13bd2aece374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA062196
Marketing category
ANDA
Marketing start
1996-04-05
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
2021-12-31
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 productproduct53002-9291DDiscontinued by firm2026-08-03
excluded packagepackage53002-929153002-9291-1DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-9291-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-9291-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-9291-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-9291-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-9291-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-9291-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-9291-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-9291-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-9291-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-9291-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-9291-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-9291-1557ba5c1ecfa…9c80585c8c6e…

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
A062196-001GENTAMICIN SULFATEGENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062196-001AT

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 UTC2026-02A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062196-001GENTAMICIN SULFATEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATApproved before 1982cb3db0bc1861…

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 UTC2026-02A062196-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062196-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062196-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062196-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062196-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062196-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062196-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062196-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062196-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062196-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062196-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062196-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062196-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062196-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062196-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062196-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062196-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062196-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062196-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062196-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062196-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062196-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062196-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062196-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062196-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062196-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062196-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062196-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062196-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062196-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062196-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062196-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062196-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062196-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062196-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062196-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062196-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062196-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062196-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062196-001AT1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062196
application number: ANDA062196
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062196
application number: ANDA062196
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062196
application number: ANDA062196
Gentamicin SulfateGENTAMICIN SULFATEAsclemed USA, Inc.a54e5c95-609d-4d66-9573-5d1ac78fa58f2022-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062196
application number: ANDA062196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9291-1530029291015 mL in 1 BOTTLE, DROPPER (53002-9291-1) 5 ml2019-01-010000-00-00NoNoCurrent