Gentamicin

Product NDC: 0404-9866
11-digit product format: 004049866
Labeler code: 0404
Product ID: 0404-9866_65ca54d7-de8c-4c5f-b47e-393f24de2af9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc
Application: ANDA062366
Marketing category: ANDA
Marketing start: 2022-01-10
Substance: GENTAMICIN SULFATE
Active strength: 40 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTAMICIN SULFATE	40 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
313996	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
84f6eb1c-a287-489a-8c3e-aa5954cf1992	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
d3946667-8212-d1f2-67e1-5643a329bb56	Product name	2	20200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477	Product name	2	20190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9866-20	Gentamicin	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20		6
0404-9866-20	Gentamicin	1 in 1 BAG	INJECTION, SOLUTION	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9866	GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [HENRY SCHEIN, INC]	5	Current NDC, Legacy NDC, 2 package rows	20240901_84f6eb1c-a287-489a-8c3e-aa5954cf1992.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 · 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 ndc (product): 0404-9866
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313996	gentamicin sulfate 40 MG/ML Injectable Solution	PSN	84f6eb1c-a287-489a-8c3e-aa5954cf1992	6
313996	gentamicin 40 MG/ML Injectable Solution	SCD	84f6eb1c-a287-489a-8c3e-aa5954cf1992	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9866-20	00404986620	1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20) / 20 mL in 1 VIAL, MULTI-DOSE	2022-01-10	0000-00-00	No	No	Current