TOBRAMYCIN AND DEXAMETHASONE

Product NDC: 50090-8046
11-digit product format: 500908046
Labeler code: 50090
Product ID: 50090-8046_df944ee5-37c5-4a6e-b906-f1b4d8668614
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tobramycin and dexamethasone
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA212715
Marketing category: ANDA
Marketing start: 2022-03-17
Substance: TOBRAMYCIN; DEXAMETHASONE
Active strength: 3; 1 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:34	2026-08	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212715-001	TOBRAMYCIN AND DEXAMETHASONE	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	2022-02-11	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	A212715-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212715-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: TOBRAMYCIN AND DEXAMETHASONE
Listing expiration: 2027-12-31

Active Ingredients#

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

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 · 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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-8046-0	50090804600	1 BOTTLE, PLASTIC in 1 CARTON (50090-8046-0) / 2.5 mL in 1 BOTTLE, PLASTIC	2026-09-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin and Dexamethasone Ophthalmic Suspension, USP Sterile	A-S Medication Solutions	2026-09-16	HUMAN PRESCRIPTION DRUG LABEL	1