Tobramycin and Dexamethasone

Product NDC: 68071-1821
11-digit product format: 680711821
Labeler code: 68071
Product ID: 68071-1821_2d96b39b-7f36-79c4-e063-6294a90acfbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin and Dexamethasone
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA064134
Marketing category: ANDA
Marketing start: 1999-10-27
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1821-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1821-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1821-2	`0efc9e666f02…`	`f202fb6c5f17…`

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
A064134-001	TOBRAMYCIN AND DEXAMETHASONE	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB		1999-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064134-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064134-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	1999-10-27	`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	A064134-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064134-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064134-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064134-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064134-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064134-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064134-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064134-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064134-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064134-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064134-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064134-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064134-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064134-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064134-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064134-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064134-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064134-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064134-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064134-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064134-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064134-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064134-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064134-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064134-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064134-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064134-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064134-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064134-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064134-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064134-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064134-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064134-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064134-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064134-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064134-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064134-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064134-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064134-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064134-001	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
b7b39ad5-e158-b8fe-e053-2995a90a5279	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
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
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
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
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
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1821-2	2025-02-06	C162847	48780-1	2cef2736-926e-d83d-e063-dadaa90ab31f	b7b39ad5-e158-b8fe-e053-2995a90a5279
68071-1821-2	2025-01-30	C162847	48780-1	2cef2736-926e-d83d-e063-dadaa90ab31f	b7b39ad5-e158-b8fe-e053-2995a90a5279

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1821-2	Tobramycin and Dexamethasone	1 in 1 CARTON	SUSPENSION/ DROPS	1		4
68071-1821-2	Tobramycin and Dexamethasone	2.5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	2.5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1821	TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250210_b7b39ad5-e158-b8fe-e053-2995a90a5279.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Sportpharm LLC	fa3d2fda-6857-4ef1-8dae-a2877f7569af	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	c33e84ba-4c0c-f738-e053-2995a90aa20a	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Sportpharm LLC	7ed85675-bc46-4dd6-bb8f-7e98c3eb84e2	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	cdd9086d-821f-4ac8-bc49-f1869dffb150	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	b7b39ad5-e158-b8fe-e053-2995a90a5279	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134 ndc (product): 68071-1821
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	61693e79-81d1-3162-e053-2a91aa0ae925	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Bausch & Lomb Incorporated	33de419e-a89b-47e5-952b-87e837f5d531	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064134 application number: ANDA064134

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	b7b39ad5-e158-b8fe-e053-2995a90a5279	4
309683	dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension	SCD	b7b39ad5-e158-b8fe-e053-2995a90a5279	4
309683	dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension	SY	b7b39ad5-e158-b8fe-e053-2995a90a5279	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1821-2	68071182102	1 BOTTLE, DROPPER in 1 CARTON (68071-1821-2) / 2.5 mL in 1 BOTTLE, DROPPER	2020-12-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin and Dexamethasone - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2025-02-07	HUMAN PRESCRIPTION DRUG LABEL	4