Home NDC 0065-0648-35 TobraDex
Product NDC 0065-0648
Requested package NDC 0065-0648-35
11-digit product format 000650648
Labeler code 0065
Product ID 0065-0648_ab313ed7-5b46-4426-a9fb-e40af786394d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tobramycin and dexamethasone
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA050616
Marketing category NDA
Marketing start 1988-10-15
Marketing end 2022-06-30
Substance TOBRAMYCIN; DEXAMETHASONE
Active strength 3 mg/g; mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# 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
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 0065-0648-35 00065064835 1 TUBE in 1 CARTON (0065-0648-35) > 3.5 g in 1 TUBE 1 tube 1988-10-15 2022-06-30 No No Current