Home NDC 0078-0876 TobraDex
Product NDC 0078-0876
11-digit product format 000780876
Labeler code 0078
Product ID 0078-0876_81fcc79f-0170-4a8c-a938-f440a3d48dbf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tobramycin and dexamethasone
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA050616
Marketing category NDA
Marketing start 1988-10-15
Substance TOBRAMYCIN; DEXAMETHASONE
Active strength 3; 1 mg/g; mg/g
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 N050616-001 TOBRADEX DEXAMETHASONE; TOBRAMYCIN 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28
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 · 43 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 2026-09-14 22:38:34 2026-08 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050616-001 TOBRADEX 0.1%;0.3% OINTMENT / OPHTHALMIC RLD, RS 1988-09-28 f41ea6bd6efb…
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 TobraDex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOBRAMYCIN 3 mg/g DEXAMETHASONE 1 mg/g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208821 Internal RxNorm lookup 309682 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0876-01 TobraDex 3.5 g in 1 TUBE OINTMENT 3.5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0876 TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION] 7 Current NDC, Legacy NDC, 1 package rows 20250226_7f310e0e-0d3b-493d-b6c4-238493a2a9b9.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TobraDex TOBRAMYCIN AND DEXAMETHASONE Novartis Pharmaceuticals Corporation 7f310e0e-0d3b-493d-b6c4-238493a2a9b9 2026-07-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 050616 application number: NDA050616 ndc (product): 0078-0876
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0876-01 00078087601 3.5 g in 1 TUBE (0078-0876-01) 3.5 g 2020-10-27 0000-00-00 No No Current