TOBREX

Product NDC: 0078-0813
11-digit product format: 000780813
Labeler code: 0078
Product ID: 0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tobramycin
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA050555
Marketing category: NDA
Marketing start: 1981-06-28
Substance: TOBRAMYCIN
Active strength: 3 mg/g
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN	3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZ8RRZ51VK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207850	Internal RxNorm lookup
313414	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
5b66bba3-cf97-4a9c-b618-ba5f277f20f6	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	Strength	SPL version
0078-0813-01	TOBREX	3.5 g in 1 TUBE	OINTMENT	3.5		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0813-01	GM - Gram	0078-0813	2b90e6f9-5b1a-4656-841a-ad9ff5594bda	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0813	TOBREX (TOBRAMYCIN) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION]	5	Current NDC, Legacy NDC, 1 package rows	20250226_5b66bba3-cf97-4a9c-b618-ba5f277f20f6.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
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 ndc (product): 0078-0813

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	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6
207850	Tobrex 0.3 % Ophthalmic Ointment	PSN	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6
207850	tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobrex]	SBD	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6
313414	tobramycin 0.003 MG/MG Ophthalmic Ointment	SCD	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6
313414	tobramycin 0.3 % Ophthalmic Ointment	SY	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6
207850	Tobrex 0.003 MG/MG Ophthalmic Ointment	SY	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6
207850	Tobrex 0.3 % Ophthalmic Ointment	SY	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0813-01	00078081301	3.5 g in 1 TUBE (0078-0813-01)	3.5 g	2022-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOBREX ® (tobramycin ophthalmic ointment) 0.3%	Novartis Pharmaceuticals Corporation	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	6