TOBRAMYCIN

Product NDC: 55150-470
11-digit product format: 551500470
Labeler code: 55150
Product ID: 55150-470_a4205ba6-2eba-4e4e-a2d4-b54447ed85f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOBRAMYCIN
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA217519
Marketing category: ANDA
Marketing start: 2023-06-21
Substance: TOBRAMYCIN SULFATE
Active strength: 1.2 g/30mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217519-001	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217519-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION		2023-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION		2023-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217519-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217519-001	AP	1	`caaa826d4ba7…`
2025-08-23 18:47 UTC	2025-08	A217519-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217519-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217519-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217519-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217519-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217519-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217519-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217519-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217519-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217519-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217519-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217519-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217519-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217519-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217519-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217519-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217519-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217519-001	AP	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217519-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN SULFATE	1.2 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HJT0RXD7JK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597823	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
c37c251f-92e9-40f0-8b0c-00d42875d776	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
9cfa145f-dbe9-bc02-83c2-692786ef6676	Product name	9	20210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796	Product name	4	20210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277	Product name	4	20210625
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55150-470-06	2024-01-30	C162847	48780-1	1030e365-365b-111a-e063-dadaa90a10e2	Tobramycin for Injection, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-470-01	TOBRAMYCIN	30 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, POWDER, LYOPHILIZED,	30		2
55150-470-06	TOBRAMYCIN	6 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	6		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-470-01	EA - Each	55150-470	0481f10c-cec1-4353-b422-90422538c884	1	2023-08-08
55150-470-06	EA - Each	55150-470	825dfc87-2e8a-46a0-8b88-ca9bab06eb00	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-470	TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]	2	Current NDC, 2 package rows	20240709_c37c251f-92e9-40f0-8b0c-00d42875d776.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
TOBRAMYCIN	TOBRAMYCIN	Eugia US LLC	c37c251f-92e9-40f0-8b0c-00d42875d776	2024-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217519 application number: ANDA217519 ndc (product): 55150-470

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HJT0RXD7JK	TOBRAMYCIN SULFATE	49842-07-1	TOBRAMYCIN SULFATE
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597823	tobramycin 40 MG/ML Injectable Solution	PSN	c37c251f-92e9-40f0-8b0c-00d42875d776	2
597823	tobramycin 40 MG/ML Injectable Solution	SCD	c37c251f-92e9-40f0-8b0c-00d42875d776	2
597823	tobramycin (as tobramycin sulfate) 40 MG/ML Injectable Solution	SY	c37c251f-92e9-40f0-8b0c-00d42875d776	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55150-470-01	55150047001	30 mL in 1 VIAL, PHARMACY BULK PACKAGE	30 ml				Historical
55150-470-06	55150047006	6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-470-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (55150-470-01)		2023-06-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin for Injection, USP Rx only	Eugia US LLC \| EUGIA PHARMA SPECIALITIES LIMITED	2024-07-06	Human Prescription Drug Label	2