Tobramycin

Product NDC: 63323-306
11-digit product format: 633230306
Labeler code: 63323
Product ID: 63323-306_c55fcee9-70c7-4926-bee6-014c0b133249
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOBRAMYCIN SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA065122
Marketing category: ANDA
Marketing start: 2005-11-23
Substance: TOBRAMYCIN 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63323-306		D	Discontinued by firm	2026-08-17
excluded product	product	63323-306		D	Discontinued by firm	2026-08-17
excluded package	package	63323-306	63323-306-26	D	Discontinued by firm	2026-08-17
excluded package	package	63323-306	63323-306-55	D	Discontinued by firm	2026-08-17
excluded package	package	63323-306	63323-306-56	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-306-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-306-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-306-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-306-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-306-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-306-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-306-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-306-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-306-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-306-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-306-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-306-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-306-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-306-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-306-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-306-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-306-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-306-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-306-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-306-55	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-306-26	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63323-306-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63323-306-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63323-306-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63323-306-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63323-306-55	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63323-306-26	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63323-306-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63323-306-55	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63323-306-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63323-306-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63323-306-55	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63323-306-26	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63323-306-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63323-306-55	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63323-306-26	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065122-001	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29
A065122-002	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065122-001	AP
A065122-002	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	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2002-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2002-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2002-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2002-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065122-001	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2002-11-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065122-002	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`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	A065122-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065122-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065122-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065122-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065122-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065122-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065122-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065122-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065122-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065122-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065122-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065122-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065122-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065122-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065122-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065122-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065122-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065122-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065122-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065122-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065122-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065122-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065122-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065122-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065122-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065122-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065122-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065122-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065122-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065122-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065122-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065122-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065122-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065122-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065122-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065122-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065122-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065122-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065122-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065122-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN 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
HJT0RXD7JK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313416	Internal RxNorm lookup
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
d6dd9460-b030-479a-b3e3-03606e6fcad1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-306-01	Tobramycin	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	7
63323-306-02	Tobramycin	25 in 1 TRAY	INJECTION, SOLUTION	25	7
63323-306-05	Tobramycin	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	7
63323-306-30	Tobramycin	10 in 1 TRAY	INJECTION, SOLUTION	10	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-306-01	ML - Milliliter	63323-306	32d8a91f-0441-4b5b-9ba7-9d919b23668a	1	2024-08-12
63323-306-02	ML - Milliliter	63323-306	3253bbde-aa65-4597-9fd2-58f18237b6c0	1	2013-02-13
63323-306-05	ML - Milliliter	63323-306	4fb1fc7c-b01b-4544-8f72-171a4df81664	1	2025-02-10
63323-306-26	ML - Milliliter	63323-306	8cae4f7f-f64a-4c85-97f6-58ac3cd1a393	1	2019-12-10
63323-306-30	ML - Milliliter	63323-306	fa2f483e-ba48-4530-9462-63deb6cf2dfb	1	2013-02-13
63323-306-55	ML - Milliliter	63323-306	7d1b10a8-315f-4521-910c-1e97dc512067	1	2013-06-04
63323-306-56	ML - Milliliter	63323-306	f01c736c-ca51-4ae5-bc4a-b94242e4a648	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOBRAMYCIN SULFATE	ACTIVE INGREDIENT	HJT0RXD7JK	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
PHENOL	INACTIVE INGREDIENT	339NCG44TV	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-306	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	7	Current NDC, Legacy NDC, 4 package rows	20240302_d6dd9460-b030-479a-b3e3-03606e6fcad1.zip
63323-306	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2	Current NDC, Legacy NDC	20240402_0b4a4b00-7f78-4e95-b870-f88fea73348e.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 SULFATE	Fresenius Kabi USA, LLC	d6dd9460-b030-479a-b3e3-03606e6fcad1	2024-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065122 application number: ANDA065122 ndc (product): 63323-306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HJT0RXD7JK	TOBRAMYCIN SULFATE	49842-07-1	TOBRAMYCIN SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313416	tobramycin 10 MG/ML Injectable Solution	PSN	d6dd9460-b030-479a-b3e3-03606e6fcad1	7
597823	tobramycin 40 MG/ML Injectable Solution	PSN	d6dd9460-b030-479a-b3e3-03606e6fcad1	7
313416	tobramycin 10 MG/ML Injectable Solution	SCD	d6dd9460-b030-479a-b3e3-03606e6fcad1	7
597823	tobramycin 40 MG/ML Injectable Solution	SCD	d6dd9460-b030-479a-b3e3-03606e6fcad1	7
313416	tobramycin (as tobramycin sulfate) 10 MG/ML Injectable Solution	SY	d6dd9460-b030-479a-b3e3-03606e6fcad1	7
597823	tobramycin (as tobramycin sulfate) 40 MG/ML Injectable Solution	SY	d6dd9460-b030-479a-b3e3-03606e6fcad1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-306-01	63323030601	2 mL in 1 VIAL, MULTI-DOSE	2 ml					Historical
63323-306-02	63323030602	25 VIAL, MULTI-DOSE in 1 TRAY (63323-306-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-306-01)		2005-11-23	0000-00-00	No	No	Current
63323-306-05	63323030605	30 mL in 1 VIAL, MULTI-DOSE	30 ml					Historical
63323-306-26	63323030626	25 VIAL, MULTI-DOSE in 1 TRAY (63323-306-26) > 2 mL in 1 VIAL, MULTI-DOSE		2005-11-23	0000-00-00	No	No	Current
63323-306-30	63323030630	10 VIAL, MULTI-DOSE in 1 TRAY (63323-306-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-306-05)		2005-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin Injection, USP	Fresenius Kabi USA, LLC	2024-03-29	HUMAN PRESCRIPTION DRUG LABEL	2
TOBRAMYCIN Injection, USP	Fresenius Kabi USA, LLC	2024-02-05	HUMAN PRESCRIPTION DRUG LABEL	7