Tobramycin

Product NDC: 76420-092
Requested package NDC: 76420-092-05
11-digit product format: 764200092
Labeler code: 76420
Product ID: 76420-092_b2696acf-8175-16fb-e053-2a95a90aa378
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Asclemed USA, Inc.
Application: ANDA207444
Marketing category: ANDA
Marketing start: 2017-06-28
Substance: TOBRAMYCIN
Active strength: 3 mg/mL
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
A207444-001	TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207444-001	AT

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207444-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207444-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207444-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207444-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207444-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207444-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207444-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207444-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207444-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207444-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207444-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207444-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207444-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207444-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207444-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207444-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207444-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207444-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207444-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207444-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207444-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207444-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207444-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207444-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207444-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207444-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207444-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207444-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207444-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207444-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207444-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207444-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207444-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207444-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207444-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207444-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207444-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207444-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207444-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207444-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN	3 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313415	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
5564e780-2320-4ce7-b211-806ca99110c3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
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
76420-092-05	Tobramycin	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-092	TOBRAMYCIN SOLUTION/ DROPS [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20201027_5564e780-2320-4ce7-b211-806ca99110c3.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	St. Mary's Medical Park Pharmacy	9263df93-c558-5d9f-e053-2995a90a546c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	Sportpharm LLC	e2aa8499-2eab-4ea2-b122-6c7b1ad0c35c	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	NuCare Pharmaceuticals,Inc.	b119bfa5-33b0-84eb-e053-2995a90a2cad	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	REMEDYREPACK INC.	3596dacc-6abc-45eb-8085-fa7aaa580a1c	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	Preferred Pharmaceuticals Inc.	ad61ce34-8305-4fd3-bf88-a1e2438128cc	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	Somerset Therapeutics, LLC	7333280d-5d2a-4609-ab93-3ab7031b65db	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
TOBRAMYCIN	TOBRAMYCIN	DirectRX	87349ae8-4709-7f5a-e053-2a91aa0ae3d1	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	A-S Medication Solutions	94ef5b16-4882-4994-a905-1ee617516186	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	Proficient Rx LP	2f95ece0-62f7-47f4-b7ab-90f95fa3dc27	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	Asclemed USA, Inc.	5564e780-2320-4ce7-b211-806ca99110c3	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (package): 76420-092-05 ndc (product): 76420-092 ndc11 (package): 76420009205

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
313415	tobramycin 0.3 % Ophthalmic Solution	PSN	5564e780-2320-4ce7-b211-806ca99110c3	1
313415	tobramycin 3 MG/ML Ophthalmic Solution	SCD	5564e780-2320-4ce7-b211-806ca99110c3	1
313415	tobramycin 0.3 % Ophthalmic Solution	SY	5564e780-2320-4ce7-b211-806ca99110c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-092-05	76420009205	5 mL in 1 BOTTLE (76420-092-05)	5 ml	2020-10-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only For Topical Ophthalmic Use Only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-10-24	HUMAN PRESCRIPTION DRUG LABEL	1