Gentamicin

Product NDC: 52584-010
11-digit product format: 525840010
Labeler code: 52584
Product ID: 52584-010_7bc0efa2-f433-4e0f-bbae-f9282456b746
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: General Injectables & Vaccines, Inc
Application: ANDA062366
Marketing category: ANDA
Marketing start: 2010-09-01
Marketing end: 2023-02-28
Substance: GENTAMICIN SULFATE
Active strength: 40 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	52584-010		D	Discontinued by firm		2026-08-17
excluded package	package	52584-010	52584-010-20	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 · 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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`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	52584-010-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062366-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04
A062366-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062366-001	AP
A062366-002	AP

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A062366-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062366-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062366-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062366-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062366-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062366-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062366-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062366-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062366-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062366-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062366-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062366-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062366-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062366-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062366-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062366-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062366-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062366-002	AP	1	`bb7c543d1eb4…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	5
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	5

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin	GENTAMICIN SULFATE	Henry Schein, Inc	84f6eb1c-a287-489a-8c3e-aa5954cf1992	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	63413469-c676-48a3-a945-7d2489b535ef	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	84f5c763-1cd3-4d85-9afb-934db8666fbf	2024-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
GENTAMICIN	GENTAMICIN	HF Acquisition Co LLC, DBA HealthFirst	c1ff0cdc-ac5d-30ca-e053-2a95a90a5066	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	8bdeef7f-ad8e-46e0-a872-e945eae51d68	2023-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	09cf88af-59da-f147-e063-6294a90aac99	2023-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	0cce2238-28d3-4280-b520-ffc3067a2ffa	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	be5b414e-d598-4721-80ee-5836156ad210	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	a73a5453-c091-43fd-aae2-d992152363b1	2023-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366

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	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-010-20	52584001020	1 VIAL, MULTI-DOSE in 1 BAG (52584-010-20) > 20 mL in 1 VIAL, MULTI-DOSE	2010-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentamicin 40 mg/mL Injection, USP 20 mL Multi Dose Vial	General Injectables & Vaccines, Inc	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL	12