GENTAMICIN SULFATE

Product NDC: 51662-1597
11-digit product format: 516621597
Labeler code: 51662
Product ID: 51662-1597_0ff9b5b7-53ad-15f6-e063-6394a90a82aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GENTAMICIN SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA062420
Marketing category: ANDA
Marketing start: 2022-10-01
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 1.

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
A062420-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		1983-08-15
A062420-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP		1983-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062420-001	AP
A062420-002	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 · 82 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	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A062420-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062420-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062420-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062420-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062420-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062420-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062420-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062420-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062420-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062420-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062420-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062420-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062420-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062420-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062420-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062420-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062420-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062420-002	AP	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: GENTAMICIN SULFATE
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
1870650	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
e9fbe619-2afe-f1d7-e053-2a95a90aab29	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	SPL version
51662-1597-2	GENTAMICIN SULFATE	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	2
51662-1597-2	GENTAMICIN SULFATE	1 in 1 POUCH	INJECTION, SOLUTION	1	2
51662-1597-3	GENTAMICIN SULFATE	25 in 1 CASE	INJECTION, SOLUTION	25	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1597	GENTAMICIN SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	2	Current NDC, Legacy NDC, 3 package rows	20240524_e9fbe619-2afe-f1d7-e053-2a95a90aab29.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	977180b3-a222-4282-d485-4a3217674305	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
Gentamicin Sulfate	GENTAMICIN SULFATE	Cardinal Health 107, LLC	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
Gentamicin Sulfate	GENTAMICIN SULFATE	Henry Schein, Inc.	913a36c3-50d6-429a-a8dd-a03126d2ca08	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	3532bb39-a1a6-9d67-e063-6294a90abc0c	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
GENTAMICIN SULFATE	GENTAMICIN SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2024-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 51662-1597
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	a8b15217-cccb-2260-e053-2995a90a709d	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420

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
1870650	gentamicin sulfate 80 MG in 2 ML Injection	PSN	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2
1870650	2 ML gentamicin 40 MG/ML Injection	SCD	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2
1870650	gentamicin (as gentamicin sulfate) 80 MG per 2 ML Injection	SY	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1597-2	51662159702	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
51662-1597-3	51662159703	25 POUCH in 1 CASE (51662-1597-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1597-2) / 2 mL in 1 VIAL, SINGLE-DOSE	25 pouch	2022-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GENTAMICIN SULFATE INJECTION, USP 80mg/2mL (40mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2024-01-27	HUMAN PRESCRIPTION DRUG LABEL	2