Gentamicin Sulfate

Product NDC: 45865-672
11-digit product format: 458650672
Labeler code: 45865
Product ID: 45865-672_9ab3823b-9674-f077-e053-2995a90a740b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Medsource Pharmaceuticals
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: 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	45865-672		I	Inactivated by FDA		2026-08-03
excluded package	package	45865-672	45865-672-01	I	Inactivated by FDA		2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-672-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-672-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-672-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-672-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-672-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-672-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-672-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-672-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-672-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064048-001	AT	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-672-01	2025-01-30	C162847	48780-1	2cef2736-a459-d83d-e063-dadaa90ab31f	Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-672-01	Gentamicin Sulfate	1 in 1 CARTON	SOLUTION/ DROPS	1		2
45865-672-01	Gentamicin Sulfate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	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, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-672	GENTAMICIN SULFATE SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20191228_1f908b73-d829-4c6f-e054-00144ff8d46c.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
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	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	1f908b73-d829-4c6f-e054-00144ff8d46c	2
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	1f908b73-d829-4c6f-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-672-01	45865067201	1 BOTTLE, DROPPER in 1 CARTON (45865-672-01) > 5 mL in 1 BOTTLE, DROPPER	2015-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2