Home NDC 50090-3569-0 Tobramycin
Product NDC 50090-3569
Requested package NDC 50090-3569-0
11-digit product format 500903569
Labeler code 50090
Product ID 50090-3569_9a56a575-00df-418c-b774-6a989784e548
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application ANDA062535
Marketing category ANDA
Marketing start 1995-01-09
Marketing end 0000-00-00
Substance TOBRAMYCIN
Active strength 3 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A062535-001 TOBREX TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062535-001 AT
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3569-0 Tobramycin 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3569 TOBRAMYCIN SOLUTION [A-S MEDICATION SOLUTIONS] 5 Legacy NDC, 1 package rows 20200122_3a8dc8f9-3c93-4362-892e-72f6df9527f9.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 · 2 matching rows.
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 50090-3569-0 50090356900 5 mL in 1 BOTTLE, PLASTIC (50090-3569-0) 5 ml 2018-09-04 0000-00-00 No No Current