TOBREX

Product NDC: 0065-0644
Requested package NDC: 0065-0644-35
11-digit product format: 000650644
Labeler code: 0065
Product ID: 0065-0644_98cbf372-1955-408c-8891-04dba817ef14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tobramycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA050555
Marketing category: NDA
Marketing start: 1981-06-28
Marketing end: 0000-00-00
Substance: TOBRAMYCIN
Active strength: 3 mg/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0065-0644	0065-0644-35	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050555-001	TOBREX	TOBRAMYCIN	0.3%	OINTMENT / OPHTHALMIC		RLD, RS, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050555-001	TOBREX	0.3%	OINTMENT / OPHTHALMIC	RLD, RS, Approved before 1982	`cb3db0bc1861…`

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
0065-0644-35	GM - Gram	0065-0644	24ae6212-ff8a-4b89-a629-0995489e351c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOBRAMYCIN	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBREX (TOBRAMYCIN) OINTMENT [ALCON LABORATORIES, INC.]	5
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	TOBREX (TOBRAMYCIN) OINTMENT [ALCON LABORATORIES, INC.]	5
CHLOROBUTANOL	INACTIVE INGREDIENT	HM4YQM8WRC	TOBREX (TOBRAMYCIN) OINTMENT [ALCON LABORATORIES, INC.]	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TOBREX (TOBRAMYCIN) OINTMENT [ALCON LABORATORIES, INC.]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TOBREX (TOBRAMYCIN) OINTMENT [ALCON LABORATORIES, INC.]	5
tobramycin	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]	1
TOBRAMYCIN	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA]	1
tobramycin	ACTIVE MOIETY	VZ8RRZ51VK	TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]	1
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA]	1
chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]	1
chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TOBREX (TOBRAMYCIN) OINTMENT [REBEL DISTRIBUTORS CORP]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TOBREX (TOBRAMYCIN) OINTMENT [STAT RX LLC USA]	1

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
TOBREX	TOBRAMYCIN	Novartis Pharmaceuticals Corporation	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050555 application number: NDA050555

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313414	tobramycin 0.3 % Ophthalmic Ointment	PSN	3d4be22b-7a8c-4247-ac35-143611342de1	1
313414	tobramycin 0.3 % Ophthalmic Ointment	PSN	b1d58360-96b4-4d23-82aa-3e4872dc0136	1
207850	Tobrex 0.3 % Ophthalmic Ointment	PSN	3d4be22b-7a8c-4247-ac35-143611342de1	1
207850	Tobrex 0.3 % Ophthalmic Ointment	PSN	b1d58360-96b4-4d23-82aa-3e4872dc0136	1
207850	tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobrex]	SBD	3d4be22b-7a8c-4247-ac35-143611342de1	1
207850	tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobrex]	SBD	b1d58360-96b4-4d23-82aa-3e4872dc0136	1
313414	tobramycin 0.003 MG/MG Ophthalmic Ointment	SCD	3d4be22b-7a8c-4247-ac35-143611342de1	1
313414	tobramycin 0.003 MG/MG Ophthalmic Ointment	SCD	b1d58360-96b4-4d23-82aa-3e4872dc0136	1
313414	tobramycin 0.3 % Ophthalmic Ointment	SY	3d4be22b-7a8c-4247-ac35-143611342de1	1
313414	tobramycin 0.3 % Ophthalmic Ointment	SY	b1d58360-96b4-4d23-82aa-3e4872dc0136	1
207850	Tobrex 0.003 MG/MG Ophthalmic Ointment	SY	3d4be22b-7a8c-4247-ac35-143611342de1	1
207850	Tobrex 0.003 MG/MG Ophthalmic Ointment	SY	b1d58360-96b4-4d23-82aa-3e4872dc0136	1
207850	Tobrex 0.3 % Ophthalmic Ointment	SY	3d4be22b-7a8c-4247-ac35-143611342de1	1
207850	Tobrex 0.3 % Ophthalmic Ointment	SY	b1d58360-96b4-4d23-82aa-3e4872dc0136	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0644-35	00065064435	3.5 g in 1 TUBE (0065-0644-35)	3.5 g	1981-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOBREX ® (tobramycin ophthalmic ointment) 0.3%	Alcon Laboratories, Inc.	2023-01-31	HUMAN PRESCRIPTION DRUG LABEL	14
Tobrex tobramycin ophthalmic ointment 0.3%	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1
TOBREX - STAT RX LLC USA	STAT RX LLC USA	2010-11-19	HUMAN PRESCRIPTION DRUG LABEL	1