Gentamicin Sulfate

Product NDC
63187-560
11-digit product format
631870560
Labeler code
63187
Product ID
63187-560_d0354f86-c43a-4166-8fe2-710442ff548e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA064048
Marketing category
ANDA
Marketing start
1994-05-11
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
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-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…

Additional Listing Data#

Finished product
Yes
Brand name base
Gentamicin Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GENTAMICIN SULFATE3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8X7386QRLVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310467Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a6677a6-def5-443e-82bc-c185d41f03b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91Product name220250107
43025f0d-698c-68da-cec9-ea4261a7ef7aProduct name220250107
d3946667-8212-d1f2-67e1-5643a329bb56Product name220200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477Product name220190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-560-05Gentamicin Sulfate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
63187-560-05Gentamicin Sulfate1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-560-05ML - Milliliter63187-560618d0754-f4d1-4751-afe2-918661fe4b8912016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GENTAMICIN SULFATEACTIVE INGREDIENT8X7386QRLVGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
GENTAMICINACTIVE MOIETYT6Z9V48IKGGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RGENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-560GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20220616_3a6677a6-def5-443e-82bc-c185d41f03b7.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 · 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
ndc (product): 63187-560

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310467gentamicin sulfate 0.3 % Ophthalmic SolutionPSN3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin 3 MG/ML Ophthalmic SolutionSCD3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic SolutionSY3a6677a6-def5-443e-82bc-c185d41f03b74
310467gentamicin sulfate 3 MG/ML Ophthalmic SolutionSY3a6677a6-def5-443e-82bc-c185d41f03b74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-560-05631870560051 BOTTLE, DROPPER in 1 CARTON (63187-560-05) / 5 mL in 1 BOTTLE, DROPPER2018-12-010000-00-00NoNoCurrent