Gentamicin Sulfate in Sodium Chloride

Product NDC: 0338-0507
11-digit product format: 003380507
Labeler code: 0338
Product ID: 0338-0507_9372a876-0913-4312-bf12-be6837cab74f
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: 60 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 44.

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 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	60 mg/50mL

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
0338-0507-41	Gentamicin Sulfate in Sodium Chloride	50 mL in 1 BAG	INJECTION, SOLUTION	50		20
0338-0507-48	Gentamicin Sulfate in Sodium Chloride	100 mL in 1 BAG	INJECTION, SOLUTION	100		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0507-41	ML - Milliliter	0338-0507	2b1cfbe1-a313-4b6e-9dfe-3905d1111278	1	2012-07-24
0338-0507-48	ML - Milliliter	0338-0507	0d07c5fb-fde8-49c4-93f0-3c892d89b537	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
0338-0507	GENTAMICIN SULFATE IN SODIUM CHLORIDE (GENTAMICIN SULFATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	19	Current NDC, Legacy NDC, 2 package rows	20250214_449c9a41-d61e-49fd-b5e3-d76f74b92acf.zip

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
0338-0507-41	00338050741	50 mL in 1 BAG (0338-0507-41)	50 ml	1982-09-07	0000-00-00	No	No	Current
0338-0507-48	00338050748	100 mL in 1 BAG (0338-0507-48)	100 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	21