Tobramycin and Dexamethasone

Product NDC: 80425-0366
Requested package NDC: 80425-0366-1
11-digit product format: 804250366
Labeler code: 80425
Product ID: 80425-0366_2a998d83-7bae-3f5e-e063-6294a90acd3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin and Dexamethasone
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Advanced Rx of Tennessee, LLC
Application: NDA050592
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-11-02
Substance: DEXAMETHASONE; TOBRAMYCIN
Active strength: 1; 3 mg/mL; mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
N050592-001	TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050592-001	AB

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	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`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	N050592-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050592-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050592-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN	1 mg/mL
DEXAMETHASONE	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZ8RRZ51VK	Internal UNII lookup
7S5I7G3JQL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309683	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
09315f0b-f15a-30d5-e063-6394a90ac8dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
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
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	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
80425-0366-1	Tobramycin and Dexamethasone	5 mL in 1 BOTTLE	SUSPENSION/ DROPS	5		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0366-1	ML - Milliliter	80425-0366	dda8d509-96d2-4b7a-8923-64f4cf3c30e7	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0366	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [ADVANCED RX OF TENNESSEE, LLC]	2	Current NDC, 1 package rows	20250101_09315f0b-f15a-30d5-e063-6394a90ac8dd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	REMEDYREPACK INC.	c606945c-4ffc-4ee8-af04-a00de8ea9259	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Preferred Pharmaceuticals Inc.	8a143864-e36b-49bf-91b4-c6cc1a928031	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Sandoz Inc	05fd0c36-39b4-4a43-8490-eb8dfc0920ae	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Advanced Rx of Tennessee, LLC	09315f0b-f15a-30d5-e063-6394a90ac8dd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592 ndc (package): 80425-0366-1 ndc (product): 80425-0366 ndc11 (package): 80425036601
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	11c2ba9a-7aa3-4f78-aa2f-2a35d2671681	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	e4ddce2f-1b91-46e1-a8f0-a38394d4e672	2023-07-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309683	tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Suspension	PSN	09315f0b-f15a-30d5-e063-6394a90ac8dd	2
309683	dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension	SCD	09315f0b-f15a-30d5-e063-6394a90ac8dd	2
309683	dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension	SY	09315f0b-f15a-30d5-e063-6394a90ac8dd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0366-1	80425036601	5 mL in 1 BOTTLE (80425-0366-1)	5 ml	2023-11-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin and Dexamethasone Ophthalmic Suspension Sterile	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2