TOBRAMYCIN AND DEXAMETHASONE

Product NDC: 67296-2174
Requested package NDC: 67296-2174-5
11-digit product format: 672962174
Labeler code: 67296
Product ID: 67296-2174_44f6e6d5-a53e-e097-e063-6294a90a331a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tobramycin and dexamethasone
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Redpharm Drug
Application: ANDA212715
Marketing category: ANDA
Marketing start: 2022-03-17
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
A212715-001	TOBRAMYCIN AND DEXAMETHASONE	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB		2022-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212715-001	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.

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	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212715-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212715-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212715-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212715-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212715-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212715-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212715-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212715-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212715-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212715-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212715-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212715-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212715-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212715-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212715-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212715-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212715-001	AB	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212715-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212715-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212715-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212715-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212715-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212715-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212715-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212715-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212715-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212715-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212715-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212715-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212715-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212715-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	df4a7747-8dfa-4933-b4d2-a3d85c5f74f8	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	1884ef6f-a60c-4a82-a7dc-fd48b7176db0	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Redpharm Drug	3dd00c21-ae42-0613-e063-6394a90a8012	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715 ndc (package): 67296-2174-5 ndc (product): 67296-2174 ndc11 (package): 67296217405
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	3e541ebf-2f7e-4cc0-9928-780353aa7657	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	3e5cd7f9-1f88-4d33-be25-c362de4dc87b	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	15280680-edc0-4e5d-99ee-117a6f589307	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
Tobramycin and dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	f4c00d9c-3a17-06a0-e053-2a95a90a8413	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	8d6a8a22-fd97-43e7-a89c-b1f32710a773	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	a5f0b05b-3dec-4fe8-8106-e41e668a512d	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Bryant Ranch Prepack	3c63c481-ce57-41ca-993f-5a5b665fa1e4	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONE	TOBRAMYCIN AND DEXAMETHASONE	Padagis US LLC	7e34b1a9-8d21-41db-9070-37227975414f	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212715 application number: ANDA212715

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
3dd00c21-ae42-0613-e063-6394a90a8012	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2174-5	TOBRAMYCIN AND DEXAMETHASONE	5 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	5		2

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	3dd00c21-ae42-0613-e063-6394a90a8012	2
309683	dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension	SCD	3dd00c21-ae42-0613-e063-6394a90a8012	2
309683	dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension	SY	3dd00c21-ae42-0613-e063-6394a90a8012	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2174-5	67296217405	5 mL in 1 BOTTLE, PLASTIC (67296-2174-5)	5 ml	2022-03-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin and Dexamethasone Ophthalmic Suspension, USP Sterile	Redpharm Drug	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	2