Gentamicin Sulfate

Product NDC: 24208-580
11-digit product format: 242080580
Labeler code: 24208
Product ID: 24208-580_1dd9fcc1-daec-fa67-e063-6394a90a0139
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24208-580	24208-580-64	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A064048-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		1994-05-11

Therapeutic equivalence codes#

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

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

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A064048-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064048-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064048-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064048-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064048-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064048-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064048-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064048-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064048-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064048-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064048-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064048-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064048-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064048-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064048-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064048-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064048-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064048-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064048-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064048-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064048-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064048-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064048-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064048-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064048-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064048-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064048-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064048-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064048-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064048-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064048-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064048-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064048-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064048-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064048-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064048-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064048-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064048-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064048-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064048-001	AT	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTAMICIN SULFATE	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8X7386QRLV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
41d01350-5c4b-42fc-be5f-986ceec02bd3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91	Product name	2	20250107
43025f0d-698c-68da-cec9-ea4261a7ef7a	Product name	2	20250107
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
d3946667-8212-d1f2-67e1-5643a329bb56	Product name	2	20200403
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
4ce5dce5-e8a7-e4f6-0059-b527e4307477	Product name	2	20190501
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-580-60	Gentamicin Sulfate	1 in 1 CARTON	SOLUTION/ DROPS	1	15
24208-580-60	Gentamicin Sulfate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	15
24208-580-64	Gentamicin Sulfate	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	15
24208-580-64	Gentamicin Sulfate	1 in 1 CARTON	SOLUTION/ DROPS	1	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-580-60	ML - Milliliter	24208-580	462515c7-1366-46c5-87db-5b20a94dd6c9	1	2012-07-24
24208-580-64	ML - Milliliter	24208-580	d1064568-058d-41df-b518-a1284803ebfc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	5
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	2
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-580	GENTAMICIN SULFATE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	15	Current NDC, Legacy NDC, 4 package rows	20240723_41d01350-5c4b-42fc-be5f-986ceec02bd3.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Preferred Pharmaceuticals Inc.	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate Opth Solution	GENTAMICIN SULFATE OPTH SOLUTION	Direct_Rx	e1a5bc32-f9a0-6b33-e053-2995a90ab9ac	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	0bef2a01-69d0-cf50-e063-6294a90a4c52	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate	GENTAMICIN SULFATE	Bausch & Lomb Incorporated	41d01350-5c4b-42fc-be5f-986ceec02bd3	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048 ndc (product): 24208-580
Gentamicin Sulfate	GENTAMICIN SULFATE	A-S Medication Solutions	76fabcd6-4da3-49e3-85a1-ca4fac55a207	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	b59e49e0-640b-43c3-ad07-711d1bb154e9	2022-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	3a6677a6-def5-443e-82bc-c185d41f03b7	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8X7386QRLV	GENTAMICIN SULFATE	1405-41-0	GENTAMICIN SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	41d01350-5c4b-42fc-be5f-986ceec02bd3	15
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	41d01350-5c4b-42fc-be5f-986ceec02bd3	15
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	41d01350-5c4b-42fc-be5f-986ceec02bd3	15
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	41d01350-5c4b-42fc-be5f-986ceec02bd3	15
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	76fabcd6-4da3-49e3-85a1-ca4fac55a207	9
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	76fabcd6-4da3-49e3-85a1-ca4fac55a207	9
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	76fabcd6-4da3-49e3-85a1-ca4fac55a207	9
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	76fabcd6-4da3-49e3-85a1-ca4fac55a207	9
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	3a6677a6-def5-443e-82bc-c185d41f03b7	4
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	3a6677a6-def5-443e-82bc-c185d41f03b7	4
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	3a6677a6-def5-443e-82bc-c185d41f03b7	4
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	3a6677a6-def5-443e-82bc-c185d41f03b7	4
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	e1a5bc32-f9a0-6b33-e053-2995a90ab9ac	3
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	3
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d	3
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	3
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	e1a5bc32-f9a0-6b33-e053-2995a90ab9ac	3
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d	3
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	3
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d	3
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	e1a5bc32-f9a0-6b33-e053-2995a90ab9ac	3
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	3
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	e1a5bc32-f9a0-6b33-e053-2995a90ab9ac	3
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d	3
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	0bef2a01-69d0-cf50-e063-6294a90a4c52	2
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	c3a08907-778d-4229-9f72-20cc4f57b10c	2
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	c3a08907-778d-4229-9f72-20cc4f57b10c	2
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	0bef2a01-69d0-cf50-e063-6294a90a4c52	2
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	0bef2a01-69d0-cf50-e063-6294a90a4c52	2
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	c3a08907-778d-4229-9f72-20cc4f57b10c	2
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	c3a08907-778d-4229-9f72-20cc4f57b10c	2
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	0bef2a01-69d0-cf50-e063-6294a90a4c52	2
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	b59e49e0-640b-43c3-ad07-711d1bb154e9	1
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	6c8b45b0-f45a-4137-8228-b38e125dede5	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	b59e49e0-640b-43c3-ad07-711d1bb154e9	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	6c8b45b0-f45a-4137-8228-b38e125dede5	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	b59e49e0-640b-43c3-ad07-711d1bb154e9	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	6c8b45b0-f45a-4137-8228-b38e125dede5	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	b59e49e0-640b-43c3-ad07-711d1bb154e9	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	6c8b45b0-f45a-4137-8228-b38e125dede5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-580-60	24208058060	1 BOTTLE, DROPPER in 1 CARTON (24208-580-60) / 5 mL in 1 BOTTLE, DROPPER		1994-05-11	0000-00-00	No	No	Current
24208-580-64	24208058064	15 mL in 1 BOTTLE, DROPPER	15 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx only	Preferred Pharmaceuticals Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	3
Gentamicin Sulfate Opth Solution	Direct_Rx	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	3
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx only	REMEDYREPACK INC.	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	4
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx only	NuCare Pharmaceuticals,Inc.	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx only	Bausch & Lomb Incorporated	2024-07-22	HUMAN PRESCRIPTION DRUG LABEL	15
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx only	RPK Pharmaceuticals, Inc.	2023-11-23	HUMAN PRESCRIPTION DRUG LABEL	1
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx only	A-S Medication Solutions	2023-05-08	HUMAN PRESCRIPTION DRUG LABEL	9
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile)	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-07-19	HUMAN PRESCRIPTION DRUG LABEL	1
Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	4
Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile)	Preferred Pharmaceuticals, Inc.	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	5
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile)	A-S Medication Solutions	2017-09-13	HUMAN PRESCRIPTION DRUG LABEL	6
Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)	Unit Dose Services	2013-06-20	HUMAN PRESCRIPTION DRUG LABEL	2
Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)	Physicians Total Care, Inc.	2012-02-27	HUMAN PRESCRIPTION DRUG LABEL	3