Gentamicin Sulfate in Sodium Chloride

Product NDC: 0338-0509
11-digit product format: 003380509
Labeler code: 0338
Product ID: 0338-0509_aacff3ac-5df9-4872-b074-78930c9c9b79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gentamicin Sulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA062373
Marketing category: ANDA
Marketing start: 1982-09-07
Substance: GENTAMICIN SULFATE
Active strength: 80 mg/50mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07
A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07
A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07
A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07
A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07
A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07

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 11 · 410 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
2026-02-19 14:30 UTC	2026-02	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION		RS	1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION		RS	1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION		RS	1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION		RS	1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	AP		1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP		1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION		RS	1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	AP		1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	AP		1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION		RS	1982-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	AP		1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION			1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP		1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION		RS	1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	AP		1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	AP		1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION		RS	1982-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION			1982-09-07	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A062373-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062373-008	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062373-008	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062373-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062373-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062373-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062373-008	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062373-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062373-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062373-007	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062373-008	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062373-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062373-005	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062373-007	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062373-008	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062373-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062373-005	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062373-007	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062373-008	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062373-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062373-005	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062373-007	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062373-008	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062373-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062373-005	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062373-007	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062373-008	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062373-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062373-005	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062373-007	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062373-008	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062373-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062373-005	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062373-007	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062373-008	AP	1	`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gentamicin Sulfate in Sodium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GENTAMICIN SULFATE	80 mg/50mL

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197736	Internal RxNorm lookup
242816	Internal RxNorm lookup
310473	Internal RxNorm lookup
310477	Internal RxNorm lookup
1870631	Internal RxNorm lookup
1870633	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
449c9a41-d61e-49fd-b5e3-d76f74b92acf	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
0338-0509-41	Gentamicin Sulfate in Sodium Chloride	50 mL in 1 BAG	INJECTION, SOLUTION	50		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0509-41	ML - Milliliter	0338-0509	05f9f25e-c631-4365-b003-011cb866fe91	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0509	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	19	Current NDC, Legacy NDC, 1 package rows	20250214_449c9a41-d61e-49fd-b5e3-d76f74b92acf.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate in Sodium Chloride	GENTAMICIN SULFATE	Baxter Healthcare Corporation	449c9a41-d61e-49fd-b5e3-d76f74b92acf	2023-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062373 application number: ANDA062373 ndc (product): 0338-0509

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
242816	gentamicin sulfate 100 MG in 100 ML Injection	PSN	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
197736	gentamicin sulfate 100 MG in 50 ML Injection	PSN	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
1870631	gentamicin sulfate 120 MG in 100 ML Injection	PSN	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
1870633	gentamicin sulfate 60 MG in 50 ML Injection	PSN	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
310473	gentamicin sulfate 80 MG in 100 ML Injection	PSN	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
310477	gentamicin sulfate 80 MG in 50 ML Injection	PSN	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
310473	100 ML gentamicin 0.8 MG/ML Injection	SCD	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
242816	100 ML gentamicin 1 MG/ML Injection	SCD	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
1870631	100 ML gentamicin 1.2 MG/ML Injection	SCD	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
1870633	50 ML gentamicin 1.2 MG/ML Injection	SCD	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
310477	50 ML gentamicin 1.6 MG/ML Injection	SCD	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
197736	50 ML gentamicin 2 MG/ML Injection	SCD	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
242816	gentamicin (as gentamicin sulfate) 100 MG per 100 ML Injection	SY	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
197736	gentamicin (as gentamicin sulfate) 100 MG per 50 ML Injection	SY	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
1870631	gentamicin (as gentamicin sulfate) 120 MG per 100 ML Injection	SY	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
1870633	gentamicin (as gentamicin sulfate) 60 MG per 50 ML Injection	SY	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
310473	gentamicin (as gentamicin sulfate) 80 MG per 100 ML Injection	SY	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20
310477	gentamicin (as gentamicin sulfate) 80 MG per 50 ML Injection	SY	449c9a41-d61e-49fd-b5e3-d76f74b92acf	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0509-41	00338050941	50 mL in 1 BAG (0338-0509-41)	50 ml	1982-09-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gentamicin Sulfate in Sodium Chloride	Baxter Healthcare Corporation	2023-01-26	HUMAN PRESCRIPTION DRUG LABEL	20