GENTAMICIN SULFATE

Product NDC: 60758-188
11-digit product format: 607580188
Labeler code: 60758
Product ID: 60758-188_16002455-98e2-4456-9112-525f5a0f71b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gentamicin sulfate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Pacific Pharma, Inc.
Application: ANDA062452
Marketing category: ANDA
Marketing start: 1998-01-05
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: 2020-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60758-188		D	Discontinued by firm		2026-08-11
excluded package	package	60758-188	60758-188-05	D	Discontinued by firm		2026-08-11

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
A062452-001	GENOPTIC	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10

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	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062452-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A062452-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60758-188-05	ML - Milliliter	60758-188	d155d9ac-d56c-4938-a7d3-39ee324dd1f5	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 [PACIFIC PHARMA, INC.]	4
gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	4
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
gentamicin sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
gentamicin sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
gentamicin sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60758-188	GENTAMICIN SULFATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.]	8	Legacy NDC	20240921_0bc9fa00-1755-4989-a222-a038e970371f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GENTAMICIN SULFATE	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	85424b40-5c2d-421d-e053-2991aa0a7771	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062452 application number: ANDA062452
gentamicin sulfate	GENTAMICIN SULFATE	DIRECT RX	51a411a0-2671-4c1c-bf25-e29b32efed0c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062452 application number: ANDA062452

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	51a411a0-2671-4c1c-bf25-e29b32efed0c	8
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	51a411a0-2671-4c1c-bf25-e29b32efed0c	8
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	51a411a0-2671-4c1c-bf25-e29b32efed0c	8
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	51a411a0-2671-4c1c-bf25-e29b32efed0c	8
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	85424b40-5c2d-421d-e053-2991aa0a7771	3
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	85424b40-5c2d-421d-e053-2991aa0a7771	3
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	85424b40-5c2d-421d-e053-2991aa0a7771	3
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	85424b40-5c2d-421d-e053-2991aa0a7771	3
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	d7a27e38-0553-4d4b-8438-fed235e9b989	1
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	2e647e36-15d9-49e9-b81b-35465441e37a	1
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	1bc419d3-12a8-8965-e063-6294a90a30bd	1
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	62c5c569-ae40-4ad2-81d9-7fe44c0ae18f	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	2e647e36-15d9-49e9-b81b-35465441e37a	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	d7a27e38-0553-4d4b-8438-fed235e9b989	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	62c5c569-ae40-4ad2-81d9-7fe44c0ae18f	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	1bc419d3-12a8-8965-e063-6294a90a30bd	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	d7a27e38-0553-4d4b-8438-fed235e9b989	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	62c5c569-ae40-4ad2-81d9-7fe44c0ae18f	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	2e647e36-15d9-49e9-b81b-35465441e37a	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	1bc419d3-12a8-8965-e063-6294a90a30bd	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	62c5c569-ae40-4ad2-81d9-7fe44c0ae18f	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	2e647e36-15d9-49e9-b81b-35465441e37a	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	d7a27e38-0553-4d4b-8438-fed235e9b989	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	1bc419d3-12a8-8965-e063-6294a90a30bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60758-188-05	60758018805	1 BOTTLE, DROPPER in 1 CARTON (60758-188-05) > 5 mL in 1 BOTTLE, DROPPER	1998-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile	Redpharm Drug	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
gentamicin sulfate	DIRECT RX	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	8
GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	8
GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterile	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	4
GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
GENTAMICIN SULFATE o phthalmic s olution, USP 0.3% s terile	Pacific Pharma, Inc.	2018-07-30	HUMAN PRESCRIPTION DRUG LABEL	8
GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterile	Aidarex Pharmaceuticals LLC	2014-01-03	HUMAN PRESCRIPTION DRUG LABEL	1
GENTAMICIN SULFATE Ophthalmic Solution, USP 0.3%	Rebel Distributors Corp	2010-09-27	HUMAN PRESCRIPTION DRUG LABEL	1