Gentamicin Sulfate

Product NDC: 13985-603
11-digit product format: 139850603
Labeler code: 13985
Product ID: 13985-603_40278cbf-031b-484d-8d2d-4ddbcf24219b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: MWI
Application: ANDA064163
Marketing category: ANDA
Marketing start: 2015-03-23
Marketing end: 0000-00-00
Substance: GENTAMICIN SULFATE
Active strength: 3 mg/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	13985-603		D	Discontinued by firm		2026-08-03
excluded package	package	13985-603	13985-603-03	D	Discontinued by firm		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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13985-603-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13985-603-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13985-603-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13985-603-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13985-603-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13985-603-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13985-603-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13985-603-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13985-603-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13985-603-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13985-603-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13985-603-03	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064163-001	GENTAK	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			2001-10-12

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	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`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	A064163-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064163-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064163-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064163-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064163-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064163-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064163-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064163-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064163-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064163-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064163-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064163-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064163-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A064163-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064163-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064163-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064163-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064163-001	AT	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE OINTMENT [MWI]	1
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE OINTMENT [MWI]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	GENTAMICIN SULFATE OINTMENT [MWI]	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	GENTAMICIN SULFATE OINTMENT [MWI]	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	GENTAMICIN SULFATE OINTMENT [MWI]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	GENTAMICIN SULFATE OINTMENT [MWI]	1

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.	4add8f7b-48f0-6b6a-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064163 application number: ANDA064163
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	2098faaa-7f60-4640-8c37-19456ebba653	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064163 application number: ANDA064163

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13985-603-03	13985060303	1 TUBE in 1 CARTON (13985-603-03) > 3.5 g in 1 TUBE	1 tube	2015-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
apexa™ Gentamicin Sulfate	MWI \| Akorn Operating Company LLC \| Akorn	2022-01-27	HUMAN PRESCRIPTION DRUG LABEL	5