Tobramycin

Product NDC: 63323-307
11-digit product format: 633230307
Labeler code: 63323
Product ID: 63323-307_f600dca6-dba3-4c03-8d55-15f8dbd467fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOBRAMYCIN SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA065120
Marketing category: ANDA
Marketing start: 2004-11-30
Marketing end: 0000-00-00
Substance: TOBRAMYCIN SULFATE
Active strength: 40 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63323-307		D	Discontinued by firm		2026-08-17
excluded package	package	63323-307	63323-307-51	D	Discontinued by firm		2026-08-17

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
A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065120-001	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.

Product history page 1 of 2 · 42 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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	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	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2002-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2002-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2002-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2002-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2002-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION		RS	2002-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065120-001	TOBRAMYCIN SULFATE (PHARMACY BULK)	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2002-11-29	`e64feba35796…`

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	A065120-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065120-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065120-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065120-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065120-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065120-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065120-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065120-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065120-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065120-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065120-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065120-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065120-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065120-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065120-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065120-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065120-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065120-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A065120-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065120-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065120-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065120-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065120-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065120-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065120-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065120-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065120-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065120-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065120-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065120-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065120-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065120-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065120-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065120-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065120-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065120-001	AP	1	`a50c72e98297…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-307-51	ML - Milliliter	63323-307	5ee6551d-a1e2-4b50-9492-913a1b41537b	1	2013-02-13

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
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
63323-307	TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	5	Legacy NDC	20240209_8cfeb84f-193a-458a-bdec-205d9274e1a4.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-307-51	63323030751	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-307-51) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE	2004-11-30	0000-00-00	No	No	Current